- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350243
Coached, Coordinated, Enhanced Neonatal Transition (CCENT) (CCENT)
Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ottawa, Canada
- The Ottawa Hospital
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- BC Children's Hospital and BC Women's Hospital & Health Centre
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital Eastern Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
Toronto, Ontario, Canada
- Mount Sinai Hospital
-
-
Quebec
-
Montreal, Quebec, Canada
- McGill University Health Centre/Montreal Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria (meets at least one of the following criteria):
- Infant born ≤ 26+6 weeks of gestational age (GA)
Infant born between 27-29+6 weeks GA with ≥ 1 of the following risk factors:
i)≥ Grade III intraventricular hemorrhage with post hemorrhagic hydrocephalus ii)Retinopathy of prematurity requiring intraocular bevacizumab/ anti-vascular endothelial growth factor or laser surgery therapy iii)Requires invasive (e.g., intubated) or non-invasive (e.g., CPAP or BiPAP) at ≥ 34 weeks GA and/or supplemental oxygen at ≥ 37 weeks gestational age iv)Requires surgery for management of necrotizing enterocolitis (NEC)- stage 3
- Infant with ≥ 2 major congenital anomalies as defined by EUROCAT(13) (e.g., congenital heart disease, spina bifida, cleft palate, etc. Not including minor congenital anomalies, e.g., dysmorphic facies), and length of stay in recruiting institution ≥ 14 days.
- Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days.
Exclusion Criteria:
- Families that do not speak English or French
- Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).
- Infant will be followed by an out-of-province neonatal follow-up program or lives a significant distance from the neonatal follow up program and therefore not routinely followed by the team.
- Infant that has previously been discharged home from the NICU/hospital.
- Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCENT Intervention group
Participants will be assigned a dedicated key worker that will support families through the child's first year, in addition to standard medical care, which involves a primary care provider and/or neonatal follow-up at routine times.
|
|
No Intervention: Control group
Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parental Stress
Time Frame: 12 months
|
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Quality of Life (QoL)
Time Frame: 4 months
|
The Health Utilities Index (HUI) questionnaire provides a health-related quality of life (HRQL) score for overall health, which will be used to calculate quality-adjusted life years (QALYs) for a cost-utility analysis.
|
4 months
|
Parental Quality of Life (QoL)
Time Frame: 12 months
|
The Health Utilities Index (HUI) questionnaire provides a health-related quality of life (HRQL) score for overall health, which will be used to calculate quality-adjusted life years (QALYs) for a cost-utility analysis.
|
12 months
|
Parental Empowerment
Time Frame: 12 months
|
This outcome will be assessed using the Family Empowerment Scale (FES), which measures empowerment across three specific domains: 1) family, 2) service system, and 3) community/political.
|
12 months
|
Child Social and Emotional Development
Time Frame: 12 months
|
This outcome will be assessed using the Brief Infant-Toddler Social Emotional Assessment (BITSEA), which is a parent self-report questionnaire that is designed as a screener to identify children (1-3 years old) at risk for or currently experiencing social-emotional and/or behavioural problems.
|
12 months
|
Parent and Child Interaction
Time Frame: 12 months
|
This outcome will be assessed using the Nursing Child Assessment Satellite Training Parent-Child Interaction (NCAST-PCI), which is used assess caregiver and infant behaviour during a structured teaching task.
|
12 months
|
Maternal Depression
Time Frame: 6 weeks
|
This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days.
Composite score between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression.
|
6 weeks
|
Maternal Depression
Time Frame: 4 months
|
This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days.
Composite score between 0 to 30 will be recorded, with a score of 10 or greater indicating possible depression.
|
4 months
|
Maternal Depression
Time Frame: 12 months
|
This outcome will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), which is a screening tool used to identify those with symptoms associated with postnatal depression in the previous 7 days.
Composite score is given between 0 to 30.
Possible depression is a score of 10 or greater.
|
12 months
|
Child Development
Time Frame: 18 months
|
The Bayley Scales of Infant and Toddler Development (3rd Edition) will be used to assess neurodevelopment with separate composite scores (mean 100 ± SD 15) for cognition, language, and motor skills.
|
18 months
|
Healthcare Service Delivery
Time Frame: 12 months
|
This outcome will be assessed using the Measure of Processes of Care (MPOC20) questionnaire, which is used to measure the parent's perception of the health services they and their child receive.
|
12 months
|
Maternal Anxiety
Time Frame: 4 months
|
This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.
|
4 months
|
Maternal Anxiety
Time Frame: 12 months
|
This outcome will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, which often used in research as an indicator of caregiver distress.
|
12 months
|
Resource Utilization
Time Frame: 4 months
|
The Resource Use Questionnaire (RUQ) will assess family resource use relating to their child's medical needs, services and programs, as well as parent time losses and family out-of-pocket costs.
|
4 months
|
Resource Utilization
Time Frame: 12 months
|
The Resource Use Questionnaire (RUQ) will assess family resource use relating to their child's medical needs, services and programs, as well as parent time losses and family out-of-pocket costs.
|
12 months
|
Psychology Inflexibility
Time Frame: 6 weeks
|
The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance.
The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.
|
6 weeks
|
Psychology Inflexibility
Time Frame: 4 months
|
The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance.
The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.
|
4 months
|
Psychology Inflexibility
Time Frame: 12 months
|
The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance.
The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.
|
12 months
|
Psychology Inflexibility
Time Frame: 18 months
|
The Acceptance and Action Questionnaire (AAQ-II) a questionnaire used to measure parent psychological inflexibility or experiential avoidance.
The AAQ-II consists of seven items (e.g., "I'm afraid of my feelings," "I worry about not being able to control my worries and feelings") measured on a 1 (never true) to 7 (always true) scale.
|
18 months
|
Child Development
Time Frame: 18 months
|
The Ages and Stages Questionnaire will also be used to assess child development
|
18 months
|
Parental perception of transition experience
Time Frame: 6 weeks post discharge
|
Parental perception of transition experience will be assessed using the Pediatric Transition Experience Measure (PTEM), an 11 item parent-report questionnaire which measures a parent's perception of transition preparation and support from the hospital.
|
6 weeks post discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health System Outcomes
Time Frame: 12 months
|
The investigators will link the patient-reported evaluation of the CCENT model with health administrative data housed at the Institute for Clinical Evaluative Sciences (ICES) for consenting participants.
Case-costing methods will be used to determine direct health care costs related to inpatient (emergency department) and outpatient (pharmaceutical and home health care) services.
|
12 months
|
Social support
Time Frame: Baseline
|
The Social Support Questionnaire- Short Form (Sarason et al., 1987) is a 6 item measure of social support.
For each of the 6 items, respondents indicate the number of people available to provide support in each of 6 areas and then rate the overall level of satisfaction with the support given in each of the areas.
Scores range from 0-54 for number of people available, and satisfaction ranges from 6-36.
Higher scores indicate more support.
|
Baseline
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000057100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Prematurity
-
Stanford UniversityMedtronic - MITGCompletedIntraventricular Hemorrhage of Prematurity | Complications of PrematurityUnited States
-
Universidade Federal do MaranhãoConselho Nacional de Desenvolvimento Científico e TecnológicoUnknown
-
University of WashingtonNational Institute of Neurological Disorders and Stroke (NINDS)CompletedExtreme PrematurityUnited States
-
University of Alabama at BirminghamRecruitingPrematurity; ExtremeUnited States
-
Guilherme Sant'Anna, MDCompleted
-
University of Kansas Medical CenterCompletedComplication of PrematurityUnited States
-
Zekai Tahir Burak Women's Health Research and Education...UnknownPrematurity of FetusTurkey
-
Mansoura University Children HospitalCompletedPrematurity, Mechanical VentilationEgypt
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; German Federal Ministry of Education and Research; Société des Produits Nestlé (SPN)CompletedPrematurity of FetusGermany
Clinical Trials on CCENT Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed