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

NCT ID: NCT02024854

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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skin-to-skin

immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.

Group Type EXPERIMENTAL

skin-to-skin

Intervention Type BEHAVIORAL

standard care

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

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type BEHAVIORAL

Interventions

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skin-to-skin

Intervention Type BEHAVIORAL

standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Infants who need immediate medical interventions
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Drammen sykehus

OTHER

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

IWK Health Centre

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Håkon Bergseng, md phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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IWK Health Centre

Halifax, , Canada

Site Status

Nyfødt intensiv, Drammen sykehus

Drammen, , Norway

Site Status

Nyfødt intensiv, Sørlandet Sykehus

Kristiansand, , Norway

Site Status

NICU St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Canada Norway

References

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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.

Reference Type BACKGROUND
PMID: 27955652 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40238094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36958792 (View on PubMed)

Other Identifiers

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KC28-32

Identifier Type: -

Identifier Source: org_study_id

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