NCT03521310

Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Björn Westrup, MD PhD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33. The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.

Conditions

• Prematurity

Interventions

Type	Name	Description
PROCEDURE	Skin-to-skin	Neonates will get Skin-to-skin Contact with parent/caregiver continuously the first 6 hours after birth and as much as possible the first 72 hours after birth.
PROCEDURE	Conventional care	Neonates will get Conventional care the first 72 hours after birth

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2018-05-11
• Last updated: 2022-01-06

Locations

2 sites across 2 countries: Norway, Sweden