MedPath

NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

Not Applicable
Recruiting
Conditions
Neurodevelopmental Disorders
Registration Number
NCT06087744
Lead Sponsor
St. Justine's Hospital
Brief Summary

NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator/bed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
124
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Neurodevelopment36 weeks gestational age (GA)

Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))

Secondary Outcome Measures
NameTimeMethod
Milk consumptionTotal in mL until study completion at infants' 36 weeks gestational age.

Through charting

Parental AnxietyBaseline before randomization and every week after until 36 weeks GA

Questionnaire - State-Trait Anxiety Inventory (STAI) - 20 items with a 4-point Likert-type scale. Minimum value: 20; maximum value: 80. A higher score indicates higher anxiety.

Neurodevelopment4 months and 18 months

Bayley-IIII (Questionnaire)

Parental StressBaseline before randomization and every week after until 36 weeks GA

Questionnaire - Parental Stress Scale - Neonatal Intensive Care Unit (NICU) (PSS:NICU) - 25 items with a 5-point Likert-type. Minimum value: 25, maximum value: 100. A higher score indicates higher parental stress.

Parental sensitivity4 months ans 18 months

Recording through videos and coding with Welch Emotional Connection Screen (WECS) - 4 dimensions: mutual attraction, facial communication, vocal communication and sensitivity/reciprocity are coded on a 9-point scale from 1 to 3. Minimum value 4; maximum value 12. Higher scores indicate a better mother-child emotional connection.

Milk productionEvery day in mL until study completion at infants' 36 weeks gestational age.

Through diary

Trial Locations

Locations (2)

CHU Sainte-Justine

🇨🇦

Montréal, Quebec, Canada

CUSM

🇨🇦

Montréal, Quebec, Canada

CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
Marilyn Aita
Contact
514-343-6111
marilyn.aita@umontreal.ca

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.