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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03004677
Acronym
Neo-SIPaS
Enrollment
11
Registered
2016-12-29
Start date
2017-01-31
Completion date
2019-12-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Sleep Quality, Stress Reaction

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.

Interventions

BEHAVIORALContinuous 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.

OTHERStandard 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.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep qualityDay 1 to 5sleep diary every day for five days

Secondary

MeasureTime frameDescription
Moodday 2 to 5Mood Adjective Checklist (MACL)
BondingBaseline and 1-3 days before planned discharge from the NICU.Mother to Infant Bonding Scale (MIBS)
DepressionBaseline and 1-3 days before planned discharge from the NICU.The Edinburgh Postnatal Depression Scale, EPDS
AnxietyBaseline and 1-3 days before planned discharge from the NICU.State Trait Anxiety Inventory, STAI
ActivityDay 1-5Actigraph every day for five days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026