Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 108
- Locations
- 4
- Primary Endpoint
- cognitive scorer at two years corrected age
Study Overview
Brief Summary
The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.
Detailed Description
Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 28 Weeks to 32 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
Exclusion Criteria
- •Infants who need immediate medical interventions
Arms & Interventions
skin-to-skin
immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.
Intervention: skin-to-skin (Behavioral)
standard care
after birth the baby is transferred to the neonatal intensive care unit
Intervention: standard care (Behavioral)
Outcomes
Primary Outcomes
cognitive scorer at two years corrected age
Time Frame: 2 year
measured by Bayley Scales of Infant Development Third Edition (BSID III)
Secondary Outcomes
- change in heart rate(24 hours)
- change in body temperature(24 hours)
- change in blood glucose(24 hours)
- Nutrition(1 year)
- general movements (GM) at 3 months corrected age(3 months)
- Social/emotional competence at three months corrected age(3 months)
- Social/emotional competence at two years corrected age(2 years)
- Developmental skills at two years corrected age(2 years)
- Maternal anxiety(2 years)
- Child Behaviour(5 year)
- change in respiration frequency(24 hours)
- Social/emotional competence at two years corrected age(1 year)
- Developmental skills at two years corrected age(1 year)
- Maternal anxiety(at discharge from hospital)
- Maternal anxiety(3 months)