Clinical trial NCT03004677: Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
Official title: Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Quality
Communication
Stress Reaction
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-12-29
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Sleep quality
timeFrame: Day 1 to 5
Secondary outcomes:
measure: Mood
timeFrame: day 2 to 5
measure: Bonding
timeFrame: Baseline and 1-3 days before planned discharge from the NICU.
measure: Depression
timeFrame: Baseline and 1-3 days before planned discharge from the NICU.
measure: Anxiety
timeFrame: Baseline and 1-3 days before planned discharge from the NICU.
measure: Activity
timeFrame: Day 1-5
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: University hospital Örebro
Study officials:
affiliation: Linkoeping University
name: Evalotte Mörelius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.