NCT06087744 NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
| NCT ID | NCT06087744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Justine's Hospital |
| Condition | Neurodevelopmental Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2023-11-23 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06087744 clinical trial?
This trial is open to participants of all sexes, aged 24 Weeks or older, up to 34 Weeks, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06087744 currently recruiting?
Yes, NCT06087744 is actively recruiting participants. Contact the research team at marilyn.aita@umontreal.ca for enrollment information.
Where is the NCT06087744 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06087744 clinical trial?
NCT06087744 is sponsored by St. Justine's Hospital. The trial plans to enroll 124 participants.