Neurodevelopmental Disorders
Conditions
Keywords
NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control
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.
Interventions
BEHAVIORALNeuroN-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.
BEHAVIORALSSC alone
Skin-to-skin contact (SSC) lasting 2 hours
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 34 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Neurodevelopment | 4 months and 18 months | Cerebral discontinuity activity vs. activity with EEG |
| 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 |
| 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. |
Countries
Canada
Contacts
Primary ContactMarilyn Aita, Ph.D.
Backup ContactKate St-Arneault, Ph.D (cand.)
Outcome results
None listed