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

Premature Birth Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02024854
Study type Interventional
Source Norwegian University of Science and Technology
Contact
Status Active, not recruiting
Phase N/A
Start date February 1, 2014
Completion date December 2025
View Details
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