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

NCT ID: NCT03004677

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Quality Communication Stress Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous skin-to-skin contact

Intervention Type BEHAVIORAL

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.

Standard Care

Infants and parents will receive standard care provided in the NICU

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Evalotte Morelius

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evalotte Mörelius, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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University Hospital

Linköping, , Sweden

Site Status

University hospital Örebro

Örebro, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 33277288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30068615 (View on PubMed)

Other Identifiers

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Linkoeping University

Identifier Type: -

Identifier Source: org_study_id

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