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Clinical Trials in Canada / NCT06087744
Recruiting Not applicable

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

NCT06087744 · tracked via the Priya Life Science Canada tracker
Sponsor
St. Justine's Hospital
Phase
Not applicable
Started
2023-11-23
Last updated
2024-04-19

Condition(s) studied

Neurodevelopmental Disorders

Investigational drug(s) / intervention(s)

NeuroN-QISSC alone

NeuroN-QI: Skin-to-skin contact (SSC) lasting 2 hours with an auditory sensory stimulation 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: Skin-to-skin contact (SSC) lasting 2 hours

Study 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.

Eligibility

Sex
ALL
Min age
24 Weeks
Max age
34 Weeks
Healthy volunteers
No
Inclusion Criteria for preterm infants: * born between 24 and 33 6/7 weeks GA; * ready for SSC Inclusion criteria for mothers and fathers: * agree to do at least one SSC session/week combined with 10 min of auditory stimulation until 36 weeks of GA of their preterm infant; * mothers express breast milk for their preterm infants For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study. Exclusion criteria for preterm infants: * congenital anomalies or genetic disorders * intraventricular hemorrhage \> grade II * are small for GA defined as birth weight \<10th percentile * on postnatal day 19 (maximum days targeted for study start) * are still receiving analgesics, sedatives, paralyzing agents * are under mechanical ventilation Exclusion criteria mothers and fathers: * are aged \<18 years; * have a physical condition that does not allow the SSC * abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions * feed their preterm infant exclusively with commercial infant formula * mothers had a breast surgery that could influence their breast milk production * do not speak, read or write in French or in English

Primary outcome measure(s)

  • 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))

Trial sites (2)

FacilityCityRegionStatus
CHU Sainte-Justine Montreal Quebec Recruiting
CUSM Montreal Quebec Not Yet Recruiting

More St. Justine's Hospital trials in Canada

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Virtual Reality Distraction for Maternal Milk Expression (PILOT) Starting soon

Other trials for the same condition

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Real World Evidence on the Use of Medical Cannabis in Pediatrics Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06087744 on ClinicalTrials.gov ↗ ← All trials in Canada