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

Primary Purpose

Preterm Infant, Mothers, Parent-Child Relations

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

GP_Posit

About this trial

This is an interventional other trial for Preterm Infant focused on measuring Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GP_Posit

Control

Arm Description

Participants allocated to this arm will receive the GP_Posit intervention.

Participants in the control arm will receive usual care.

Outcomes

Primary Outcome Measures

Compliance to the protocole

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.

Content analysis of acceptability questionnaires

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.

Secondary Outcome Measures

Mother-Infant interaction

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.

Parental beliefs about preterm infant and parental role

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.

General movement assessment (GMA)

General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.

Electroencephalogram (EEG)

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.

Full Information

NCT ID

NCT03677752

First Posted

August 1, 2018

Last Updated

May 3, 2022

Sponsor

St. Justine's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03677752

Brief Title

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

Acronym

GP_Posit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

August 20, 2018 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infant, Mothers, Parent-Child Relations, Child Development, Interaction, Mother-Infant

Keywords

Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GP_Posit

Arm Type

Experimental

Arm Description

Participants allocated to this arm will receive the GP_Posit intervention.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants in the control arm will receive usual care.

Intervention Type

Other

Intervention Name(s)

GP_Posit

Other Intervention Name(s)

Guided Participation intervention to positioning

Intervention Description

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.

Primary Outcome Measure Information:

Title

Compliance to the protocole

Description

Time Frame

Through study completion, an average of 1 1/2 year.

Title

Content analysis of acceptability questionnaires

Description

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)

Secondary Outcome Measure Information:

Title

Mother-Infant interaction

Description

Time Frame

When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)

Title

Parental beliefs about preterm infant and parental role

Description

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.

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)

Title

General movement assessment (GMA)

Description

General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.

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)

Title

Electroencephalogram (EEG)

Description

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)

Other Pre-specified Outcome Measures:

Title

Maternal Anxiety

Description

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.

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)

Title

Maternal stress

Description

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.

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marilyn Aita, PhD

Organizational Affiliation

Université de Montréal

Official's Role

Study Director

Facility Information:

Facility Name

CHU Sainte-Justine

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28335806

Citation

Lavallee A, Aita M, Bourbonnais A, De Clifford-Faugere G. Effectiveness of early interventions for parental sensitivity following preterm birth: a systematic review protocol. Syst Rev. 2017 Mar 23;6(1):62. doi: 10.1186/s13643-017-0459-x.

Results Reference

background

PubMed Identifier

32509322

Citation

Lavallee A, Aita M, Cote J, Bell L, Luu TM. A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 May 26;6:77. doi: 10.1186/s40814-020-00601-5. eCollection 2020.

Results Reference

derived

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

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