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

Björn Westrup, MD PhD

Status: Terminated

Conditions: Prematurity

Treatments: Procedure: Skin-to-skin; Procedure: Conventional care

Study type: Interventional

Funder types: Other

Identifiers

NCT03521310

IPISTOSS

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born in gestation week plus days 28+0 - 32+6.
• Born at maternity ward at study center
• Consent from parents/caregivers
• Parent or caregiver or substitute are available to start skin-to-skin Contact during the first hour of life.

Exclusion criteria

• Born outside the hospital

• Triplets or more

• Known malformation which will require immediate surgical action

• On-going resuscitation or intensive Medical care (mechanic ventilation or inotropy) after the first lifespan

  * Known congenital infection

• Parent/care giver can not communicate in Swedish/Norwegian or English

• Not suited for the study for other reasons (according to the principal investigator)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Skin-to-skin Contact group

Experimental group

Description:

Neonates in gestational age between 28+0 - 32+6 will get continuous Skin-to-skin contact with one parent/caregiver the first 6 hours after birth and as much as possible the first 72 hours after birth.

Treatment:

Procedure: Skin-to-skin

Conventional care group

Active Comparator group

Description:

Neonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.

Treatment:

Procedure: Conventional care