NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
NCT ID: NCT06087744
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2023-11-23
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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NeuroN-QI
Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be 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.
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
Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.
SSC alone
Skin-to-skin contact (SSC) lasting 2 hours
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* ready for SSC
* 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
* 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
* 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
24 Weeks
34 Weeks
ALL
No
Sponsors
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St. Justine's Hospital
OTHER
Responsible Party
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Marilyn Aita
Researcher
Locations
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CHU Sainte-Justine
Montreal, Quebec, Canada
CUSM
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MP-21-2023-5375
Identifier Type: -
Identifier Source: org_study_id
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