Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
NCT ID: NCT03004677
Last Updated: 2020-03-04
Study Results
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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TERMINATED
NA
11 participants
INTERVENTIONAL
2017-01-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
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.
Standard Care
Infants and parents will receive standard care provided in the NICU
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* The family should have been transferred to family-room from intensive care
* Swedish speaking parents
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Evalotte Morelius
Associate professor
Principal Investigators
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Evalotte Mörelius, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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University Hospital
Linköping, , Sweden
University hospital Örebro
Örebro, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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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.
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.
Other Identifiers
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Linkoeping University
Identifier Type: -
Identifier Source: org_study_id
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