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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neurodevelopmental Disorders

Intervention / Treatment
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* Behavioral: NeuroN-QI
* Behavioral: SSC alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroN-QI<br>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<br>* 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.<br>|
| Active Comparator: SSC alone<br>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<br>* Skin-to-skin contact (SSC) lasting 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment | Cerebral discontinuity activity vs. activity with EEG | 4 months and 18 months | 
| Neurodevelopment | Bayley-IIII (Questionnaire) | 4 months and 18 months | 
| Parental Stress | 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. | Baseline before randomization and every week after until 36 weeks GA | 
| Parental Anxiety | 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. | Baseline before randomization and every week after until 36 weeks GA | 
| Parental sensitivity | 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. | 4 months ans 18 months | 
| Milk production | Through diary | Every day in mL until study completion at infants' 36 weeks gestational age. | 
| Milk consumption | Through charting | Total in mL until study completion at infants' 36 weeks gestational age. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control