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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Content analysis of acceptability questionnaires
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
GP_Posit
Participants allocated to this arm will receive the GP_Posit intervention.
Intervention: GP_Posit (Other)
Control
Participants in the control arm will receive usual care.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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))
- 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))
- 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))
- Mother-Infant interaction(When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge))
Investigators
Andréane Lavallée
Student
St. Justine's Hospital