NCT06087744RecruitingNot Applicable
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
St. Justine's Hospital4 sites in 1 country124 target enrollmentStarted: November 23, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 124
- Locations
- 4
- Primary Endpoint
- Neurodevelopment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 24 Weeks to 34 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Neurodevelopment
Time Frame: 36 weeks gestational age (GA)
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
Secondary Outcomes
- Milk consumption(Total in mL until study completion at infants' 36 weeks gestational age.)
- Parental Anxiety(Baseline before randomization and every week after until 36 weeks GA)
- Parental Stress(Baseline before randomization and every week after until 36 weeks GA)
- Parental sensitivity(4 months ans 18 months)
- Milk production(Every day in mL until study completion at infants' 36 weeks gestational age.)
- Neurodevelopment(4 months and 18 months)
Investigators
Marilyn Aita
Researcher
St. Justine's Hospital
Study Sites (4)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Close Collaboration and Discharge ReadinessFamily Centered CareNCT06057974Nagano Children's Hospital60
Not yet recruiting
Unknown
How Does a multicomponent Program to Prepare Parents, Affects Their Anxiety Before and After Surgery- A Randomised Controlled TrialCTRI/2024/01/061522AIIMS, Jodhpur
Terminated
Not Applicable
Early Behavioral Intervention for Preterm InfantsPremature BirthNCT02379130Columbia University36
Completed
Not Applicable
The Effectiveness of Parent-Child Interaction Therapy (PCIT)Behavior ProblemsConduct DisorderOppositional Defiant DisorderNCT01085305Norwegian University of Science and Technology63
Completed
Not Applicable
Nurturing and Quiet Intervention: NeuroN-QINeurodevelopmentNCT04593095St. Justine's Hospital24