NCT03004677

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

December 10, 2016

Last Update Submit

March 1, 2020

Conditions

Sleep QualityCommunicationStress Reaction

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    sleep diary every day for five days

    Day 1 to 5

Secondary Outcomes (5)

  • 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.

  • Anxiety

    Baseline and 1-3 days before planned discharge from the NICU.

  • Activity

    Day 1-5

Study Arms (2)

Continuous skin-to-skin contact

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

Infants and parents will receive standard care provided in the NICU

Other: Standard Care

Interventions

Continuous skin-to-skin contactBEHAVIORAL

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.

Continuous skin-to-skin contact
Standard CareOTHER

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.

Standard Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital

Linköping, Sweden

Location

University hospital Örebro

Örebro, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 33277288DERIVED

  • 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.

    PMID: 30068615DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersCommunicationFractures, Stress

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehaviorFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Evalotte Mörelius, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 10, 2016

First Posted

December 29, 2016

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)