Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
91 participants
INTERVENTIONAL
2018-04-01
2021-10-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Supporting Mothers of Preterm Infants
NCT03013660
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
NCT02024854
Immediate Skin-To-Skin Care For Preterm Infants After Birth
NCT06794164
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
NCT05975203
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
NCT05820386
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Skin-to-skin Contact group
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.
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.
Conventional care group
Neonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.
Conventional care
Neonates will get Conventional care the first 72 hours after birth
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Conventional care
Neonates will get Conventional care the first 72 hours after birth
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bergen
OTHER
Björn Westrup, MD PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Björn Westrup, MD PhD
Co-director of Karolinska NIDCAP Training and Research Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Björn Westrup, MD,PhD
Role: STUDY_CHAIR
Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden
Siren Rettedal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stavanger University Hospital, Stavanger, Norway
Wibke Jonas, Ass prof
Role: PRINCIPAL_INVESTIGATOR
Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stavanger University Hospital
Stavanger, , Norway
Department of Women´s and Children´s Health, Karolinska University Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPISTOSS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.