Clinical trial NCT06087744: NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
Official title: Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: NICU
skin to skin contact
neurodevelopment
preterm infants
positive stimulation
environmental control
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 124
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Neurodevelopment
timeFrame: 36 weeks gestational age (GA)
Secondary outcomes:
measure: Neurodevelopment
timeFrame: 4 months and 18 months
measure: Neurodevelopment
timeFrame: 4 months and 18 months
measure: Parental Stress
timeFrame: Baseline before randomization and every week after until 36 weeks GA
measure: Parental Anxiety
timeFrame: Baseline before randomization and every week after until 36 weeks GA
measure: Parental sensitivity
timeFrame: 4 months ans 18 months
measure: Milk production
timeFrame: Every day in mL until study completion at infants' 36 weeks gestational age.
measure: Milk consumption
timeFrame: Total in mL until study completion at infants' 36 weeks gestational age.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: CUSM
state: Quebec
Study officials:
References: