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

Not Applicable

Completed

• Conditions: Parent-Child Relations; Child Development; Interaction, Mother-Infant; Preterm Infant; Mothers
• Interventions: Other: GP_Posit

• Registration Number: NCT03677752
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study Start: 2018-08-20
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Primary Completion: 2020-02-28
• Study Completion: 2020-05-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP_Posit	GP_Posit	Participants allocated to this arm will receive the GP_Posit intervention.

Primary Outcome Measures

Name	Time	Method
Content analysis of acceptability questionnaires	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.
Compliance to the protocole	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.

Secondary Outcome Measures

Name	Time	Method
Parental beliefs about preterm infant and parental role	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.
General movement assessment (GMA)	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.
Electroencephalogram (EEG)	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.
Mother-Infant interaction	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.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada