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

Child Development Clinical Trial

— GP_Posit  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677752
• Other study ID #: 2017-1540
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: May 29, 2020

Study information

• Verified date: May 2022
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 29, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Hypersensitivity
• Interaction, Mother-Infant
• Mothers
• Parent-Child Relations
• Premature Birth
• Preterm Infant

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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lavallée A, Aita M, Bourbonnais A, De Clifford-Faugère 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Anxiety	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.	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	Maternal stress	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.	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)
Primary	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.
Primary	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	Mother-Infant interaction	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.	When the infant reaches 36 weeks of gestational age (after the intervention; before NICU discharge)
Secondary	Parental beliefs about preterm infant and parental role	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.	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)
Secondary	General movement assessment (GMA)	General movements of infants will be analyzed in order to analyse preterm infant's neurodevelopment.	When the infant reaches 36 weeks of gestational age (after the intervention that finished at 35 weeks of gestational age; before NICU discharge)
Secondary	Electroencephalogram (EEG)	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.	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)