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Completed

NCT Number: NCT03677752

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

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.

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Key information

Conditions

Preterm Infant Child Development Female Urogenital Diseases and Pregnancy Complications Interaction, Mother-Infant Mothers Obstetric Labor Complications Obstetric Labor, Premature Parent-Child Relations Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Guided Participation intervention to positioning

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Mother-Infant interaction

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

    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.

  2. Parental beliefs about preterm infant and parental role

    Time frame: 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)

    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.

  3. General movement assessment (GMA)

    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)

    General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.

  4. Electroencephalogram (EEG)

    Time frame: 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)

    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.

Other outcomes

  1. Maternal Anxiety

    Time frame: 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)

    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.

  2. Maternal stress

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study 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

Acronym: GP_Posit

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2018
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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