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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

St. Justine's Hospital

Investigators

  • 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)

August 20, 2018

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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