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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
124
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.
Skin-to-skin contact (SSC) lasting 2 hours
CHU Sainte-Justine
Montreal, Quebec, Canada
RECRUITINGCUSM
Montreal, Quebec, Canada
NOT_YET_RECRUITINGNeurodevelopment
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
Time frame: 36 weeks gestational age (GA)
Neurodevelopment
Cerebral discontinuity activity vs. activity with EEG
Time frame: 4 months and 18 months
Neurodevelopment
Bayley-IIII (Questionnaire)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months ans 18 months
Milk production
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Through diary
Time frame: Every day in mL until study completion at infants' 36 weeks gestational age.
Milk consumption
Through charting
Time frame: Total in mL until study completion at infants' 36 weeks gestational age.