NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

Sponsor

St. Justine's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06087744

Collaborator

(none)

124

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurodevelopmental Disorders	Behavioral: NeuroN-QI Behavioral: SSC alone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: SSC alone Skin-to-skin contact (SSC) lasting 2 hours

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

Behavioral: SSC alone

Skin-to-skin contact (SSC) lasting 2 hours

Outcome Measures

Primary Outcome Measures

Neurodevelopment [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 Outcome Measures

Neurodevelopment [4 months and 18 months]
Cerebral discontinuity activity vs. activity with EEG
Neurodevelopment [4 months and 18 months]
Bayley-IIII (Questionnaire)
Parental Stress [Baseline before randomization and every week after until 36 weeks GA]
Questionnaire - Parental Stress Scale - Neonatal Intensive Care Unit (NICU) (PSS:NICU) - 25 items with a 5-point Likert-type. Minimum value: 25, maximum value: 100. A higher score indicates higher parental stress.
Parental Anxiety [Baseline before randomization and every week after until 36 weeks GA]
Questionnaire - State-Trait Anxiety Inventory (STAI) - 20 items with a 4-point Likert-type scale. Minimum value: 20; maximum value: 80. A higher score indicates higher anxiety.
Parental sensitivity [4 months ans 18 months]
Recording through videos and coding with Welch Emotional Connection Screen (WECS) - 4 dimensions: mutual attraction, facial communication, vocal communication and sensitivity/reciprocity are coded on a 9-point scale from 1 to 3. Minimum value 4; maximum value 12. Higher scores indicate a better mother-child emotional connection.
Milk production [Every day in mL until study completion at infants' 36 weeks gestational age.]
Through diary
Milk consumption [Total in mL until study completion at infants' 36 weeks gestational age.]
Through charting

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Weeks to 34 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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