Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Premature Birth
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 2832 years
- Gender
- Both males and females
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 withd...
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.
Tracking Information
- NCT #
- NCT02024854
- Collaborators
- St. Olavs Hospital
- Drammen sykehus
- Sorlandet Hospital HF
- IWK Health Centre
- Investigators
- Study Director: Håkon Bergseng, md phd Norwegian University of Science and Technology