GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial (GP_Posit)

May 3, 2022 updated by: Andréane Lavallée, St. Justine's Hospital

Guided Participation to Positioning (GP_Posit) Intervention for Mothers of Preterm Infants in the Neonatal Intensive Care Unit for Maternal Sensitivity and Infant's Neurodevelopment: Randomized Pilot Trial

The aim of this study is to evaluate the acceptability, feasibility and preliminary effects a GP_Posit intervention. GP_Posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. Preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 (Actual)

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.
20

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 Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

This study will recruit mother-infant dyads.

Inclusion Criteria for mothers:

  • Understand, write and read French and/or English
  • Are 18 years or older

Exclusion Criteria for mothers:

  • Use drugs
  • Have an instable mental health
  • Give their newborn infant for adoption

Inclusion Criteria for preterm infants:

  • Are born at 27 0/7 et 31 6/7 weeks of gestation
  • Are hospitalized in the NICU for at least 4 weeks

Exclusion Criteria for preterm infants:

  • Require surgery
  • Have intraventricular haemorrhage (IVH) > grade 2
  • Have congenital malformations

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Experimental: GP_Posit
Participants allocated to this arm will receive the GP_Posit intervention.
Other: GP_Posit
Mother-infant dyads allocated to this arm will receive the GP_Posit intervention. The intervention consists of a guided participation intervention to positioning. Mothers will meet with the intervention nurse twice a week for the two first weeks after birth and then one a week until the infant will reach 35 weeks of gestational age. During these encounters, mothers will learn how to interpret their infant's stress and stability cues and participate in his/her care and positioning while being guided by the intervention nurse.
Other Names:
  • Guided Participation intervention to positioning
No Intervention: Control
Participants in the control arm will receive usual care.

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
Compliance to the protocole
Time Frame: Through study completion, an average of 1 1/2 year.
Compliance to the protocole to assess feasibility of the intervention GP_Posit and protocol. Research team will document aspects regarding % of recruitment, % of intervention delivered as planned, etc. through study completion. A threshold of 80% will be used to determine feasibility of the protocole elements.
Through study completion, an average of 1 1/2 year.
Content analysis of acceptability questionnaires
Time Frame: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Mothers' answers to acceptability questionnaires will be analyzed. This is a questionnaire built by the research team aimed at collecting narrative data regarding mother's acceptability of the intervention. Elements such as acceptability of the length of the intervention, frequency of encounters, etc. will be assessed.
When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)

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
Mother-Infant interaction
Time Frame: When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
Filmed mother-infant feeding will be coded to assess mother-infant interaction between the mother and the infant and maternal sensitivity to her infant's cues using the Parent-Child Interaction - Feeding Scale. The score can vary from 0-76 and a higher score is better.
When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
Parental beliefs about preterm infant and parental role
Time Frame: At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Neonatal intensive care unit: parental beliefs scale (NICU:PBS). Scale range: Likert type scale (1 to 5) where a higher score indicates better beliefs. Scores can vary from 18 to 90.
At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
General movement assessment (GMA)
Time Frame: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.
When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Electroencephalogram (EEG)
Time Frame: At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Electrical activity in the preterm brain will be measured using 8 electrodes on the infant's heads and compared before and after the intervention + between groups. We will perform spectral analyses with multiscale entropy calculation and connectivity analyses in order to see synchrony using the phase slope index.
At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Anxiety
Time Frame: At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
State-trait anxiety inventory (STAI). Likert type scale with scores ranging from 1 to 4. A higher score indicates a worst outcome (more anxiety). Total score can range from 20 to 80.
At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Maternal stress
Time Frame: At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Parental stressor scale: NICU Scale range: Likert type scale (1 to 5) where a higher score indicates higher levels of stress. The three subscales will be reported independently. First subscale can vary from 0 to 25. Second subscale can vary from 0 to 70. Third subscale can vary from 0 to 35.
At entry in the study and when the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)

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.
St. Justine's Hospital

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.
  • Study Director: Marilyn Aita, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
August 20, 2018

Primary Completion (Actual)

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.
February 28, 2020

Study Completion (Actual)

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.
May 29, 2020

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).
August 1, 2018

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.
September 18, 2018

First Posted (Actual)

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.
September 19, 2018

Study Record Updates

Last Update Posted (Actual)

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 9, 2022

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 3, 2022

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, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2017-1540

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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