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

Not Applicable

Recruiting

• Conditions: Neurodevelopmental Disorders
• Interventions: Behavioral: NeuroN-QI; Behavioral: SSC alone

• 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

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Study Start: 2023-11-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2026-10
• Study Completion: 2027-10

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

Arm && Interventions

Group	Intervention	Description
NeuroN-QI	NeuroN-QI	Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.
SSC alone	SSC alone	Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.

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