Nurturing and Quiet Intervention: NeuroN-QI

Not Applicable

Completed

• Conditions: Neurodevelopment
• Interventions: Other: NeuroN-QI

• Registration Number: NCT04593095
• Lead Sponsor: St. Justine's Hospital

Brief Summary

The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2021-06-01
• Status Verified: 2023-11
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Infants:

• born between 26 and 316/7 WGA.

Mothers

• agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
• express breast milk for their infant;
• speak, read, or write French or English.

Nurses:

• have at least 6 months of work experience in a NICU;
• speak and read French or English.

Exclusion Criteria

Infants:

• have birth defects or genetic disorders;
• have an intraventricular hemorrhage > grade II;
• receive nasal respiratory support;
• have been transferred from another hospital.

Mothers:

• are <18 years of age;
• had a multiparous birth;
• have a physical condition that does not allow SSC;
• abuse substances or alcohol;
• do not intend to breastfeed or give breastmilk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	NeuroN-QI	Each SSC session will last 2-hr during the day including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise. The 2-hr SSC will be followed by a 1-hr quiet period where infants will rest in their incubator/crib with a pad immersed with their mother breast milk for olfactory stimulation and where the control of light and noise levels will be continued. The NeuroN-QI will be done 4 times/wk for each dyad.

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)	1 year	questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant

Secondary Outcome Measures

Name	Time	Method
Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU	1 year
Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire	1 year	questionnaire completed by nurses - each question treated separately from totally feasible to totally unfeasible (no total score)
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)	1 year	Observation by videos
Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y	1 year
Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire	1 year	questionnaire completed by nurses - each question treated separately from totally acceptable to totally unacceptable (no total score)
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)	1 year	Observation scale by videos
Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire	1 year	Questionnaire completed by nurses - each question treated separately from strongly disagree to totally strongly agree (no total score)

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada