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Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

NCT03521310 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2022-01-06

No results posted yet for this study

Summary

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33.

The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.

Conditions

  • Prematurity

Interventions

PROCEDURE

Skin-to-skin

Neonates will get Skin-to-skin Contact with parent/caregiver continuously the first 6 hours after birth and as much as possible the first 72 hours after birth.

PROCEDURE

Conventional care

Neonates will get Conventional care the first 72 hours after birth

Sponsors & Collaborators

  • Björn Westrup, MD PhD

    lead OTHER

  • University of Bergen

    collaborator OTHER

Principal Investigators

  • Björn Westrup, MD,PhD · Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden

  • Siren Rettedal, MD, PhD · Stavanger University Hospital, Stavanger, Norway

  • Wibke Jonas, Ass prof · Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-10-12
Completion
2021-10-12

Countries

  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521310 on ClinicalTrials.gov