Status:
RECRUITING
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
Lead Sponsor:
St. Justine's Hospital
Conditions:
Neurodevelopmental Disorders
Eligibility:
All Genders
24-34 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06087744
Start Date
November 23 2023
End Date
October 1 2027
Last Update
April 19 2024
Active Locations (2)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
2
CUSM
Montreal, Quebec, Canada, H4A 3J1