Clinical trial NCT03677752: GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Mothers
Parent-Child Relations
Child Development
Interaction, Mother-Infant
Keywords: Intervention
Maternal sensitivity
Neurodevelopment
Maternal stress
Maternal anxiety
Neonatal intensive care unit
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Compliance to the protocole
timeFrame: Through study completion, an average of 1 1/2 year.
measure: Content analysis of acceptability questionnaires
timeFrame: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Secondary outcomes:
measure: Mother-Infant interaction
timeFrame: When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
measure: Parental beliefs about preterm infant and parental role
timeFrame: 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)
measure: General movement assessment (GMA)
timeFrame: When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
measure: Electroencephalogram (EEG)
timeFrame: 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 outcomes:
measure: Maternal Anxiety
timeFrame: 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)
measure: Maternal stress
timeFrame: 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)
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Marilyn Aita, PhD
role: STUDY_DIRECTOR
References:
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.
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.