Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 108
- Locations
- 4
- Primary Endpoint
- cognitive scorer at two years corrected age
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
Exclusion Criteria
- •Infants who need immediate medical interventions
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 blood glucose(24 hours)
- Nutrition(1 year)
- general movements (GM) at 3 months corrected age(3 months)
- change in body temperature(24 hours)
- 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)