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Experimental for Neurodevelopmental Disorder (NeuroN-QI Trial)

N/A
Waitlist Available
Led By Marilyn Aita, PhD
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
have at least 6 months of work experience in a NICU;
speak and read French or English.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

NeuroN-QI Trial Summary

Nurturing and Quiet Intervention: NeuroN-QI

NeuroN-QI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

NeuroN-QI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
Secondary outcome measures
Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)
+4 more
Other outcome measures
Confounding variables

NeuroN-QI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Mothers-infant dyads will do 4 SSC/wk. During these sessions, no attempt will be made by the RA to control the light and noise levels nor to encourage auditory stimulation. The SSC periods will not be followed by a quiet period nor olfactory stimulation.

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
196 Previous Clinical Trials
78,999 Total Patients Enrolled
Marilyn Aita, PhDPrincipal InvestigatorSt. Justine's Hospital
3 Previous Clinical Trials
126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nurturing and Quiet Intervention: NeuroN-QI
Marilyn Aita 2021. "Nurturing and Quiet Intervention: NeuroN-QI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04593095.
~8 spots leftby Apr 2025
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