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

B

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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