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Clinical Trials/NCT03004677
NCT03004677
Terminated
Not Applicable

Effect of Skin-to-skin Contact on Interaction and Parents' Sleep

Linkoeping University3 sites in 1 country11 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Quality
Sponsor
Linkoeping University
Enrollment
11
Locations
3
Primary Endpoint
Sleep quality
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care.

Detailed Description

The intervention is based on a method developed to facilitate closeness and human touch between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns to care for the infant in SSC.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Evalotte Morelius

Associate professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • Parents staying at the NICU with a single preterm infant born \<33 weeks of gestation
  • The family should have been transferred to family-room from intensive care
  • Swedish speaking parents

Exclusion Criteria

  • Infants with major congenital malformation,
  • Infants with intraventricular hemorrhage grade III-IV
  • Infants with chromosome defect that could affect the infant´s ability to interact.
  • Parents with sleeping disorder
  • Parents with psychiatric problem or drug use.

Outcomes

Primary Outcomes

Sleep quality

Time Frame: Day 1 to 5

sleep diary every day for five days

Secondary Outcomes

  • Mood(day 2 to 5)
  • Bonding(Baseline and 1-3 days before planned discharge from the NICU.)
  • Depression(Baseline and 1-3 days before planned discharge from the NICU.)
  • Activity(Day 1-5)
  • Anxiety(Baseline and 1-3 days before planned discharge from the NICU.)

Study Sites (3)

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