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

Not Applicable

Active, not recruiting

• Conditions: Premature Birth
• Interventions: Behavioral: skin-to-skin; Behavioral: standard care

• Registration Number: NCT02024854
• Lead Sponsor: Norwegian University of Science and Technology

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 Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-28
• Study First Posted: 2013-12-31
• Study Start: 2014-02-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)

Exclusion Criteria

• Infants who need immediate medical interventions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skin-to-skin	skin-to-skin	immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.
standard care	standard care	after birth the baby is transferred to the neonatal intensive care unit

Primary Outcome Measures

Name	Time	Method
cognitive scorer at two years corrected age	2 year	measured by Bayley Scales of Infant Development Third Edition (BSID III)

Secondary Outcome Measures

Name	Time	Method
change in heart rate	24 hours
change in blood glucose	24 hours
Nutrition	1 year	based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.
general movements (GM) at 3 months corrected age	3 months	assessed with the General Movement Assessment (GMA)
change in body temperature	24 hours
Social/emotional competence at three months corrected age	3 months	measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Social/emotional competence at two years corrected age	2 years	measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Developmental skills at two years corrected age	2 years	measured with the Ages and Stages Questionnaire: (ASQ)
Maternal anxiety	2 years	measured with State-Trait Anxiety Inventory (STAI)
Child Behaviour	5 year	Measured with Child Behaviour Checklist
change in respiration frequency	24 hours

Trial Locations

Locations (4)

NICU St Olavs Hospital; 🇳🇴 Trondheim, Norway

Nyfødt intensiv, Sørlandet Sykehus; 🇳🇴 Kristiansand, Norway

Nyfødt intensiv, Drammen sykehus; 🇳🇴 Drammen, Norway

IWK Health Centre; 🇨🇦 Halifax, Canada