Effect of Skin-to-skin Contact on Interaction and Parents' Sleep (Neo-SIPaS)

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.

Study Overview

• Status: Terminated
• Conditions: Communication; Sleep Quality; Stress Reaction
• Intervention / Treatment: Behavioral: Continuous skin-to-skin contact; Other: 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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden
    • University Hospital
  • Uppsala, Sweden
    • Uppsala University Hospital
  • Örebro, Sweden
    • University hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Continuous skin-to-skin contact; Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.
Active Comparator: Standard Care; Infants and parents will receive standard care provided in the NICU	Other: Standard Care; Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	sleep diary every day for five days	Day 1 to 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Evalotte Mörelius, PhD, Linkoeping University

Publications and helpful links

General Publications

• Morelius E, Olsson E, Sahlen Helmer C, Thernstrom Blomqvist Y, Angelhoff C. External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study. BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991.
• Angelhoff C, Blomqvist YT, Sahlen Helmer C, Olsson E, Shorey S, Frostell A, Morelius E. Effect of skin-to-skin contact on parents' sleep quality, mood, parent-infant interaction and cortisol concentrations in neonatal care units: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 1;8(7):e021606. doi: 10.1136/bmjopen-2018-021606.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 10, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: Linkoeping University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO