NCT02024854

Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	skin-to-skin
BEHAVIORAL	standard care

Timeline

• Start date: 2014-02-01
• Primary completion: 2022-12-31
• Completion: 2025-12-01
• First posted: 2013-12-31
• Last updated: 2025-06-10

Locations

4 sites across 2 countries: Canada, Norway