NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neurodevelopment 36 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
Name Time Method Milk consumption Total in mL until study completion at infants' 36 weeks gestational age. Through charting
Parental Anxiety Baseline 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.
Neurodevelopment 4 months and 18 months Bayley-IIII (Questionnaire)
Parental Stress Baseline 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 sensitivity 4 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 production Every 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, CanadaMarilyn AitaContact514-343-6111marilyn.aita@umontreal.ca