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

Not Applicable

Terminated

• Conditions: Communication; Sleep Quality; Stress Reaction
• Interventions: Other: Standard Care; Behavioral: Continuous skin-to-skin contact

• Registration Number: NCT03004677
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Infants and parents will receive standard care provided in the NICU
Continuous skin-to-skin contact	Continuous skin-to-skin contact	Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents.

Primary Outcome Measures

Name	Time	Method
Sleep quality	Day 1 to 5	sleep diary every day for five days

Secondary Outcome Measures

Name	Time	Method
Mood	day 2 to 5	Mood Adjective Checklist (MACL)
Bonding	Baseline and 1-3 days before planned discharge from the NICU.	Mother to Infant Bonding Scale (MIBS)
Depression	Baseline and 1-3 days before planned discharge from the NICU.	The Edinburgh Postnatal Depression Scale, EPDS
Activity	Day 1-5	Actigraph every day for five days
Anxiety	Baseline and 1-3 days before planned discharge from the NICU.	State Trait Anxiety Inventory, STAI

Trial Locations

Locations (3)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

University Hospital; 🇸🇪 Linkoping, Sweden

University hospital Örebro; 🇸🇪 Örebro, Sweden