Intervention to support neurodevelopment in preterm infants
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
NA · St. Justine's Hospital · NCT06087744
This study tests a special program for preterm infants that includes skin-to-skin contact with parents and soothing sounds to see if it helps their brain development.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 24 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | St. Justine's Hospital (other) |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06087744 on ClinicalTrials.gov |
What this trial studies
NeuroN-QI evaluates the effects of an intervention designed for preterm infants that includes skin-to-skin contact with parents and auditory stimulation through the parents' voice. The intervention also incorporates calm periods with olfactory stimulation using breast milk, all while maintaining appropriate light and noise levels. This approach aims to enhance neurodevelopmental outcomes in preterm infants by providing positive sensory experiences during their critical early weeks. The study will involve both parents and infants, particularly focusing on those born between 24 and 33 weeks of gestational age.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born between 24 and 33 weeks of gestational age who are ready for skin-to-skin contact.
Not a fit: Patients with congenital anomalies, genetic disorders, or those requiring mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve neurodevelopmental outcomes for preterm infants.
How similar studies have performed: Other studies have shown promising results with similar interventions focusing on sensory stimulation for preterm infants.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec and 1 other locations
- CHU Sainte-Justine — Montreal, Quebec, Canada (RECRUITING)
- CUSM — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Marilyn Aita, Ph.D.
- Email: marilyn.aita@umontreal.ca
- Phone: 514-343-6111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurodevelopmental Disorders, NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control