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

Communication Clinical Trial

— Neo-SIPaS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03004677
• Other study ID #: Linkoeping University
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communication
• Fractures, Stress
• Sleep Quality
• Stress Reaction

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	University Hospital	Linkoping
Sweden	University hospital Örebro	Örebro
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

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