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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677752
Other study ID # 2017-1540
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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