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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: standard care; Behavioral: skin-to-skin

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Halifax, Canada
    • IWK Health Centre
• Norway
  • Drammen, Norway
    • Nyfødt intensiv, Drammen sykehus
  • Kristiansand, Norway
    • Nyfødt intensiv, Sørlandet Sykehus
  • Trondheim, Norway
    • NICU St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: skin-to-skin; immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.	Behavioral: skin-to-skin
Active Comparator: standard care; after birth the baby is transferred to the neonatal intensive care unit	Behavioral: standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive scorer at two years corrected age	measured by Bayley Scales of Infant Development Third Edition (BSID III)	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Sorlandet Hospital HF; St. Olavs Hospital; IWK Health Centre; Drammen sykehus
• Investigators: Study Director: Håkon Bergseng, md phd, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Kristoffersen L, Stoen R, Rygh H, Sognnaes M, Follestad T, Mohn HS, Nissen I, Bergseng H. Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):593. doi: 10.1186/s13063-016-1730-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 28, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Kangaroo-Mother Care Method; Stress, Physiological
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: KC28-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No