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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Drammen sykehus | OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
| IWK Health Centre |
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The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.
Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| skin-to-skin | Experimental | immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours. |
|
| standard care | Active Comparator | after birth the baby is transferred to the neonatal intensive care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin-to-skin | Behavioral |
| ||
| standard care |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive scorer at two years corrected age | measured by Bayley Scales of Infant Development Third Edition (BSID III) | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| change in heart rate | 24 hours | |
| change in body temperature | 24 hours | |
| change in respiration frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Håkon Bergseng, md phd | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Canada | ||||
| Nyfødt intensiv, Drammen sykehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27955652 | Background | Kristoffersen L, Stoen R, Rygh H, Sognnaes M, Follestad T, Mohn HS, Nissen I, Bergseng H. Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):593. doi: 10.1186/s13063-016-1730-5. | |
| 40238094 | Derived | Kristoffersen L, Stoen R, Bergseng H, Flottorp ST, Mageroy G, Grunewaldt KH, Aker K. Immediate Skin-to-Skin Contact in Very Preterm Neonates and Early Childhood Neurodevelopment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255467. doi: 10.1001/jamanetworkopen.2025.5467. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
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|
| 24 hours |
| change in blood glucose | 24 hours |
| general movements (GM) at 3 months corrected age | assessed with the General Movement Assessment (GMA) | 3 months |
| Nutrition | based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health. | 1 year |
| Social/emotional competence at three months corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 3 months |
| Social/emotional competence at two years corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 1 year |
| Social/emotional competence at two years corrected age | measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE) | 2 years |
| Developmental skills at two years corrected age | measured with the Ages and Stages Questionnaire: (ASQ) | 1 year |
| Developmental skills at two years corrected age | measured with the Ages and Stages Questionnaire: (ASQ) | 2 years |
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | at discharge from hospital |
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | 3 months |
| Maternal anxiety | measured with State-Trait Anxiety Inventory (STAI) | 2 years |
| Child Behaviour | Measured with Child Behaviour Checklist | 5 year |
| Drammen |
| Norway |
| Nyfødt intensiv, Sørlandet Sykehus | Kristiansand | Norway |
| NICU St Olavs Hospital | Trondheim | Norway |
| 36958792 | Derived | Kristoffersen L, Bergseng H, Engesland H, Bagstevold A, Aker K, Stoen R. Skin-to-skin contact in the delivery room for very preterm infants: a randomised clinical trial. BMJ Paediatr Open. 2023 Mar;7(1):e001831. doi: 10.1136/bmjpo-2022-001831. |
| D000091642 | Urogenital Diseases |