NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
1 other identifier
interventional
124
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
November 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 19, 2024
April 1, 2024
2.9 years
September 13, 2023
April 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurodevelopment
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
36 weeks gestational age (GA)
Secondary Outcomes (7)
Neurodevelopment
4 months and 18 months
Neurodevelopment
4 months and 18 months
Parental Stress
Baseline before randomization and every week after until 36 weeks GA
Parental Anxiety
Baseline before randomization and every week after until 36 weeks GA
Parental sensitivity
4 months ans 18 months
- +2 more secondary outcomes
Study Arms (2)
NeuroN-QI
EXPERIMENTALRandomized 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.
SSC alone
ACTIVE COMPARATORRandomized 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- born between 24 and 33 6/7 weeks GA;
- 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.
You may not qualify if:
- 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
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
CUSM
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
September 13, 2023
First Posted
October 18, 2023
Study Start
November 23, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share