NCT02024854

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

8.9 years

First QC Date

December 19, 2013

Last Update Submit

June 5, 2025

Conditions

Premature Birth

Keywords

Kangaroo-Mother Care MethodStress, Physiological

Outcome Measures

Primary Outcomes (1)

  • cognitive scorer at two years corrected age

    measured by Bayley Scales of Infant Development Third Edition (BSID III)

    2 year

Secondary Outcomes (15)

  • 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

    3 months

  • +10 more secondary outcomes

Study Arms (2)

skin-to-skin

EXPERIMENTAL

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

standard care

ACTIVE COMPARATOR

after birth the baby is transferred to the neonatal intensive care unit

Behavioral: standard care

Interventions

skin-to-skinBEHAVIORAL
skin-to-skin
standard careBEHAVIORAL
standard care

Eligibility Criteria

Age28 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Infants who need immediate medical interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IWK Health Centre

Halifax, Canada

Location

Nyfødt intensiv, Drammen sykehus

Drammen, Norway

Location

Nyfødt intensiv, Sørlandet Sykehus

Kristiansand, Norway

Location

NICU St Olavs Hospital

Trondheim, Norway

Location

Related Publications (3)

  • 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.

    PMID: 27955652BACKGROUND

  • Kristoffersen L, Stoen R, Bergseng H, Flottorp ST, Mageroy G, Grunewaldt KH, Aker K. Immediate Skin-to-Skin Contact in Very Preterm Neonates and Early Childhood Neurodevelopment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255467. doi: 10.1001/jamanetworkopen.2025.5467.

    PMID: 40238094DERIVED

  • Kristoffersen L, Bergseng H, Engesland H, Bagstevold A, Aker K, Stoen R. Skin-to-skin contact in the delivery room for very preterm infants: a randomised clinical trial. BMJ Paediatr Open. 2023 Mar;7(1):e001831. doi: 10.1136/bmjpo-2022-001831.

    PMID: 36958792DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Håkon Bergseng, md phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 31, 2013

Study Start

February 1, 2014

Primary Completion

December 31, 2022

Study Completion

December 1, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

CA(1)NO(3)