Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

May 2, 2023 updated by: Marsha Campbell-Yeo, IWK Health Centre

Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU Using an eHealth Solution (The CONNECT Study)

Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 800 parents and their babies, who are expected to stay at least 5 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents who have an infant admitted to the NICU
  • Parents who provide consent to participate within 7 days following birth
  • Infant (regardless of gestational age or diagnosis) is anticipated to have at least a 5-day NICU stay

Exclusion Criteria:

  • Parents who are unable to read or write English
  • Parents whose infant is not anticipated to survive within the 7-day enrollment period after birth based on attending physician assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group with Standard Care
Consenting families in the NICU during the baseline control period will receive standard care as it is already provided at each site. Data collection procedures will mirror intervention groups to ensure comparable control data.
Experimental: Intervention Group Receiving CNH+
Eligible consenting families (following enrollment) will be provided a secure login code and instructions to access the CNH+ educational modules and to send and receive virtual calls and text messages. Parents will be asked to use CNH+ during their entire NICU stay. To ensure equity, interested families without a personal device to access CNH+ will be offered a study-provided iPad for the duration of their infant's stay. Parents will have access to CNH+ while on the unit and 6 months post-discharge.
Behavioral: CNH+
CNH+ is a bundled intervention targeting all four of Bandura's factors associated with improved self-efficacy (i.e., Mastery [evidence-based parent targeted education platform]; Vicarious Experience [observing other families similar to them succeeding in a task i.e., videos and photos]; Verbal Persuasion [in-person/virtual medical rounds and provision of social support]; and Physiological States [notifications and encouragement through mHealth text messaging, parent feedback, and tailored clinical care pathway]).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy at their infant's discharge from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 21 days (after the infant is born)
Time Frame: At baseline and 21 days after the infant is born
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and 21 days after the infant admitted to the NICU is born. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
At baseline and 21 days after the infant is born
Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 6 months (after the infant is discharged from the NICU)
Time Frame: At baseline and 6 months after the infant is discharged from the NICU
In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy 6 months after the infant is discharged from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment, and 6 months after the infant is discharged from the NICU. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).
At baseline and 6 months after the infant is discharged from the NICU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at their infant's discharge from the NICU? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at 21 days (after the infant is born)
Time Frame: At baseline and at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at 21 days after the infant is born? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).
At baseline and at 21 days (after the infant is born)
Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at their infant's discharge from the NICU? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at 21 days (after the infant is born)
Time Frame: At baseline and at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at 21 days after the infant is born? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).
At baseline and at 21 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level of depression at their infant's discharge from the NICU? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 14 days (after the infant is born)
Time Frame: At baseline and at 14 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level depression at 14 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and at 14 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
At baseline and at 14 days (after the infant is born)
Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 21 days (after the infant is born)
Time Frame: At baseline and at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental level depression at 21 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).
At baseline and at 21 days (after the infant is born)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental quality of life at their infant's discharge from the NICU? Measured using the Quality of Life (EQ-5D-5L) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).
At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at 21 days (after the infant is born)
Time Frame: At baseline and at 21 days (after the infant is born)
In parents of NICU infants, does CNH+, when compared to standard care, change parental quality of life at 21 days after the infant is born? Measured using the Quality of Life (EQ-5D-5L) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).
At baseline and at 21 days (after the infant is born)
Perceived amount of family-centred care in the NICU (as measured using the Family Centred Care Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived amount of family-centred care in the NICU at their infant's discharge from the NICU? Measured using the Family Centred Care Scale tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Family Centred Care Scale has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of perceived amount of family-centred care in the NICU).
At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived amount of family engagement in care in the NICU (as measured using the CO-PARTNER Tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived amount of family engagement in care in the NICU at their infant's discharge from the NICU? Measured using the CO-PARTNER Tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The CO-PARTNER Tool has a minimum score of 0 and a maximum score of 62. A higher score indicates a better outcome (higher levels of positive inherent relationship between participation and collaboration).
At infant discharge date (immediately after the infant is discharged from the NICU)
Perceived parental readiness to have their infant discharged from the NICU and sent home (as measured using the Readiness for Hospital Discharge tool) at infant discharge date (immediately after the infant is discharged from the NICU)
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived readiness to have their infant discharged from the NICU and sent home, at the time of their infant's discharge from the NICU? Measured using the Readiness for Hospital Discharge tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Readiness for Hospital Discharge tool has a minimum average score of 0 and a maximum score of 10. A higher score indicates a better outcome (higher levels of readiness for hospital discharge).
At infant discharge date (immediately after the infant is discharged from the NICU)
Infant weight growth (change in weight since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change infant weight growth (change in weight since birth) at the infant's discharge from the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Infant head growth (change in head circumference since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change infant head growth (change in head circumference since birth) at the infant's discharge from the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Infant length of stay in the NICU (in days) at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change infant length of stay in the NICU (in days) at the infant's discharge from the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU, totalled at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change the amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Infant receipt of breast milk at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In parents of NICU infants, does CNH+, when compared to standard care, change the receipt of breast milk for their infant at the infant's discharge from the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Amount of time for the infant to reach full enteral feeds during their stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the amount of time for the infant to reach full enteral feeds during their stay in the NICU? Data collected by chart review.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of mortality during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of mortality during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of necrotizing enterocolitis (Stage >II) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of necrotizing enterocolitis (Stage >II) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of late-onset sepsis during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of late-onset sepsis during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of chronic lung disease during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of chronic lung disease during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of retinopathy of prematurity (Stage ≥3) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of retinopathy of prematurity (Stage ≥3) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of severe brain injury during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of severe brain injury during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of treated Patent Ductus Arteriosus (PDA) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of treated Patent Ductus Arteriosus (PDA) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Incidence of air leak during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the incidence of air leak during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of respiratory support (invasive and non-invasive) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the duration of respiratory support (invasive and non-invasive) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of oxygen supplementation during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the duration of oxygen supplementation during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of total parenteral nutrition (TPN) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the duration of total parenteral nutrition (TPN) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Duration of hypoxic ischemic encephalopathy (HIE) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the duration of hypoxic ischemic encephalopathy (HIE) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant's days with a central venous line in situ during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the number of infant's days with a central venous line in situ during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Number of infant central line-associated bloodstream infections during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
Time Frame: At infant discharge date (immediately after the infant is discharged from the NICU)
In NICU infants, does CNH+, when compared to standard care, change the number of infant central line-associated bloodstream infections during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.
At infant discharge date (immediately after the infant is discharged from the NICU)
Infant neurological examination score at 18 months corrected gestational age
Time Frame: At 18 months of the infants corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a neurological examination? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
At 18 months of the infants corrected gestational age
Infant hearing assessment score at 18 months corrected gestational age
Time Frame: At 18 months of the infants corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a hearing assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
At 18 months of the infants corrected gestational age
Infant vision assessment score at 18 months corrected gestational age
Time Frame: At 18 months of the infants corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a vision assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
At 18 months of the infants corrected gestational age
Infant development score at 18 months corrected gestational age
Time Frame: At 18 months of the infants corrected gestational age
In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through the Bayley Scales of Infant and Toddler Development? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.
At 18 months of the infants corrected gestational age
Number of Chez NICU Home educational modules completed at 6 months after the discharge of the infant from the NICU.
Time Frame: At 6 months after the discharge of the infant from the NICU
What number of Chez NICU Home educational modules are completed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
At 6 months after the discharge of the infant from the NICU
Number of Chez NICU Home educational modules viewed at 6 months after the discharge of the infant from the NICU.
Time Frame: At 6 months after the discharge of the infant from the NICU
What number of Chez NICU Home educational modules are viewed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
At 6 months after the discharge of the infant from the NICU
Amount of time spent on the Chez NICU Home platform at 6 months after the discharge of the infant from the NICU.
Time Frame: At 6 months after the discharge of the infant from the NICU
What amount of time do parents of infants in the NICU spend on the Chez NICU Home platform, at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.
At 6 months after the discharge of the infant from the NICU
Number of text messages received by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
Time Frame: At 6 months after the discharge of the infant from the NICU
What number of text messages are received by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by TextIt application.
At 6 months after the discharge of the infant from the NICU
Number of virtual communication tools used by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
Time Frame: At 6 months after the discharge of the infant from the NICU
What number of virtual communication tools are used by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by CNH+.
At 6 months after the discharge of the infant from the NICU
Number of parents of infants in the NICU who enroll in CNH+ when offered?
Time Frame: At baseline (upon enrollment to the study)
What number of parents of infants in the NICU who enroll in CNH+ when offered at the beginning of the study?
At baseline (upon enrollment to the study)
Parents' perceived ease of use of the CNH+ intervention (as measured using the e-Health impact questionnaire) at 6 months after the discharge of the infant from the NICU)
Time Frame: At 6 months after the discharge of the infant from the NICU
In parents of NICU infants, what are parents' perceived ease of use of the CNH+ intervention at 6 months after the discharge of the infant from the NICU)? Measured using the e-Health impact questionnaire tool 6 months after the discharge of the infant from the NICU. The primary parent/caregiver(s) will be asked to complete this measure. When scored, the e-Health impact questionnaire tool has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of perceived ease of use).
At 6 months after the discharge of the infant from the NICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IWK Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marsha Campbell-Yeo, RN NNP PhD, Dalhousie University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CONNECT 1028664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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