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

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ClinicalTrials.gov Identifier: NCT03677752
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Andréane Lavallée, 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Mothers Parent-Child Relations Child Development Interaction, Mother-Infant Other: GP_Posit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: GP_Posit
Participants allocated to this arm will receive the GP_Posit intervention.
Other: GP_Posit
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.
Other Name: Guided Participation intervention to positioning

No Intervention: Control
Participants in the control arm will receive usual care.



Primary Outcome Measures :
  1. Welch Emotional Connexion Scale (WECS) [ Time Frame: When the infant reaches 35 weeks of gestational age (after the intervention; before NICU discharge) ]
    Filmed mother-infant interaction will be coded to assess emotional connexion between the mother and the infant and maternal sensitivity to her infant's cues. Each of the four subscales scores range from 1 to 5, 5 indicating a better outcome.

  2. 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 recruitment, delivery of the intervention, etc. through study completion. A threshold of 80% will be used to determine feasibility of the protocole elements.

  3. Content analysis of acceptability questionnaires [ Time Frame: When the infant reaches 35 weeks of gestational age (after the intervention; 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.


Secondary Outcome Measures :
  1. Maternal stress [ Time Frame: At entry in the study and when the infant reaches 35 weeks of gestational age (after the intervention; before NICU discharge) ]
    Parental stressor scale: NICU Scale range: Likert type scale (1 to 5) where a higher score indicates higher levels of stress. The three subscales will be reported independently. First subscale can vary from 0 to 25. Second subscale can vary from 0 to 70. Third subscale can vary from 0 to 35.

  2. Maternal Anxiety [ Time Frame: At entry in the study and when the infant reaches 35 weeks of gestational age (after the intervention; before NICU discharge) ]
    State-trait anxiety inventory (STAI). Likert type scale with scores ranging from 1 to 4. A higher score indicates a worst outcome (more anxiety). Total score can range from 20 to 80.

  3. Parental beliefs about preterm infant and parental role [ Time Frame: At entry in the study and when the infant reaches 35 weeks of gestational age (after the intervention; 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.

  4. General movement assessment (GMA) [ Time Frame: When the infant reaches 35 weeks of gestational age (after the intervention; before NICU discharge) ]
    General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.

  5. Electroencephalogram [ Time Frame: At entry in the study and when the infant reaches 35 weeks of gestational age (after the intervention; before NICU discharge) ]
    Electrical activity in the preterm brain will be measured using 7 electrodes on the infant's heads and compared before and after the intervention + between groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

This study will recruit mother-infant dyads.

Inclusion Criteria for mothers:

  • Understand, write and read French and/or English
  • Are 18years 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 28 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677752


Contacts
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Contact: Andréane Lavallée, PhD (c) 514-343-6111 ext 51473 andreane.lavallee@umontreal.ca

Locations
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Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Andréane Lavallée, PhD (c)    514-248-2994    andreane.lavallee@umontreal.ca   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Study Director: Marilyn Aita, PhD Université de Montréal

Publications:
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Responsible Party: Andréane Lavallée, Student, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03677752     History of Changes
Other Study ID Numbers: 2017-1540
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andréane Lavallée, St. Justine's Hospital:
Intervention
Maternal sensitivity
Neurodevelopment
Maternal stress
Maternal anxiety
Neonatal intensive care unit

Additional relevant MeSH terms:
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Premature Birth
Hypersensitivity
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Immune System Diseases