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

NCT03677752 | Completed

• 1 other identifier: 2017-1540
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mother-Infant interaction

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

• 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)

Other Outcomes (2)

• Maternal Anxiety

  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)

• Maternal stress

  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)

Study Arms (2)

GP_Posit

EXPERIMENTAL

Participants allocated to this arm will receive the GP\_Posit intervention.

Other: GP_Posit

Control

NO INTERVENTION

Participants in the control arm will receive usual care.

Interventions

GP_Posit OTHER

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.

Also known as: Guided Participation intervention to positioning

GP_Posit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand, write and read French and/or English
• Are 18 years or older

You may not qualify if:

• Use drugs
• Have an instable mental health
• Give their newborn infant for adoption
• Are born at 27 0/7 et 31 6/7 weeks of gestation
• Are hospitalized in the NICU for at least 4 weeks
• Require surgery
• Have intraventricular haemorrhage (IVH) \> grade 2
• Have congenital malformations

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 28335806 BACKGROUND

• 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.

  PMID: 32509322 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marilyn Aita, PhD

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 19, 2018
• Study Start: August 20, 2018
• Primary Completion: February 28, 2020
• Study Completion: May 29, 2020
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)