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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: GP_Posit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP_Posit<br>Participants allocated to this arm will receive the GP_Posit intervention. | Other: GP_Posit<br>* 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.<br>* Other names: Guided Participation intervention to positioning;|
| No Intervention: Control<br>Participants in the control arm will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 1/2 year. | 
| 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. | 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 | 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 | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Maternal sensitivity, Neurodevelopment, Maternal stress, Maternal anxiety, Neonatal intensive care unit