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

NCT03521310 | Terminated DMC

• 1 other identifier: IPISTOSS
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

IPISTOSS; Skin to skin; SSC; Neonatal; kangaroo mother care

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory stability

  Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability

  After six hours

Secondary Outcomes (32)

• Need for respiratory support

  After 3 months

• Need for surfactant

  After 3 months

• Need of Continuous positive airway pressure

  After 3 months

• Need for oxygen

  After 3 months

• Heart Rate Variability

  Up to 3-4 months

Study Arms (2)

Skin-to-skin Contact group

EXPERIMENTAL

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.

Procedure: Skin-to-skin

Conventional care group

ACTIVE COMPARATOR

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

Procedure: Conventional care

Interventions

Skin-to-skin PROCEDURE

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.

Skin-to-skin Contact group

Conventional care PROCEDURE

Neonates will get Conventional care the first 72 hours after birth

Conventional care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Björn Westrup, MD PhD: lead
• University of Bergen: collaborator

Study Sites (2)

Stavanger University Hospital

Stavanger, Norway

Location

Department of Women´s and Children´s Health, Karolinska University Hospital

Stockholm, SE 171 77, Sweden

Location

Related Publications (2)

• Lillieskold S, Lode-Kolz K, Rettedal S, Lindstedt J, Linner A, Markhus Pike H, Ahlqvist-Bjorkroth S, Aden U, Jonas W. Skin-to-Skin Contact at Birth for Very Preterm Infants and Mother-Infant Interaction Quality at 4 Months: A Secondary Analysis of the IPISTOSS Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344469. doi: 10.1001/jamanetworkopen.2023.44469.

  PMID: 38032643 DERIVED

• Linner A, Westrup B, Lode-Kolz K, Klemming S, Lillieskold S, Markhus Pike H, Morgan B, Bergman NJ, Rettedal S, Jonas W. Immediate parent-infant skin-to-skin study (IPISTOSS): study protocol of a randomised controlled trial on very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences. BMJ Open. 2020 Jul 6;10(7):e038938. doi: 10.1136/bmjopen-2020-038938.

  PMID: 32636292 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Björn Westrup, MD,PhD

  Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden

  STUDY CHAIR

• Siren Rettedal, MD, PhD

  Stavanger University Hospital, Stavanger, Norway

  PRINCIPAL INVESTIGATOR

• Wibke Jonas, Ass prof

  Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-director of Karolinska NIDCAP Training and Research Center

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: May 11, 2018
• Study Start: April 1, 2018
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NO (1)