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

Primary Purpose

Sleep Quality, Communication, Stress Reaction

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Continuous skin-to-skin contact
Standard Care
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Quality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital
  • Uppsala University Hospital
  • University hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous skin-to-skin contact

Standard Care

Arm Description

Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents.

Infants and parents will receive standard care provided in the NICU

Outcomes

Primary Outcome Measures

Sleep quality
sleep diary every day for five days

Secondary Outcome Measures

Mood
Mood Adjective Checklist (MACL)
Bonding
Mother to Infant Bonding Scale (MIBS)
Depression
The Edinburgh Postnatal Depression Scale, EPDS
Anxiety
State Trait Anxiety Inventory, STAI
Activity
Actigraph every day for five days

Full Information

First Posted
December 10, 2016
Last Updated
March 1, 2020
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03004677
Brief Title
Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
Acronym
Neo-SIPaS
Official Title
Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
To difficult to recruit.
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Communication, Stress Reaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous skin-to-skin contact
Arm Type
Experimental
Arm Description
Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Infants and parents will receive standard care provided in the NICU
Intervention Type
Behavioral
Intervention Name(s)
Continuous skin-to-skin contact
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep quality
Description
sleep diary every day for five days
Time Frame
Day 1 to 5
Secondary Outcome Measure Information:
Title
Mood
Description
Mood Adjective Checklist (MACL)
Time Frame
day 2 to 5
Title
Bonding
Description
Mother to Infant Bonding Scale (MIBS)
Time Frame
Baseline and 1-3 days before planned discharge from the NICU.
Title
Depression
Description
The Edinburgh Postnatal Depression Scale, EPDS
Time Frame
Baseline and 1-3 days before planned discharge from the NICU.
Title
Anxiety
Description
State Trait Anxiety Inventory, STAI
Time Frame
Baseline and 1-3 days before planned discharge from the NICU.
Title
Activity
Description
Actigraph every day for five days
Time Frame
Day 1-5

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evalotte Mörelius, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Linkoping
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Name
University hospital Örebro
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33277288
Citation
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.
Results Reference
derived
PubMed Identifier
30068615
Citation
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.
Results Reference
derived

Learn more about this trial

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

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