title: Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.
abstract: Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at St. Olav's University Hospital. In the present study we aim to investigate whether skin-to-skin care following delivery is safe, and how it affects early and late outcomes compared to standard care for very preterm infants.
  
  
  
  A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 280-316weeks with birth weight >1000 grams. Infants with severe congenital malformations or need of intubation in the delivery room are excluded. A detailed checklist and a flowchart were prepared for the study, and all involved professionals (neonatologists, neonatal nurses, obstetricians, anesthesiologists, midwives) participated in medical simulation training prior to study start on February 1, 2014. A consultant in neonatology and a neonatal nurse are present at all deliveries. Infants with birth weight <1500 grams receive an intravenous line with glucose, amino acids, and caffeine citrate in the delivery room. Infants with gestational age <30 weeks are routinely put on continuous positive airway pressure (CPAP). After initial stabilization, infants are randomized to skin-to-skin care or are transferred to the nursery in an incubator. Primary outcome is cognitive development at 2 years measured with the Bayley Scales of Infant Development, Third Edition. Secondary outcomes are safety defined as hypothermia, respiratory failure, and/or cardiopulmonary resuscitation, physiological stability after birth and motor, language and cognitive development at 1 year for the child, and mental health measured with the State-Trait Anxiety Inventory (STAI) at discharge, and at 3 months and 2 years after expected date of delivery for the mothers.
  
  
  
  The study may have important implications for the initial care for very preterm infants after delivery and increase our understanding of how early skin-to-skin care affects preterm infants and their mothers.
  
  
  
  ClinicalTrials, NCT02024854 . Registered on 19 December 2013.
authors.affiliation: Department of Pediatrics, St. Olav's University Hospital, Trondheim, Norway. Laila.kristoffersen@ntnu.no.|Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, NTNU, Trondheim, Norway. Laila.kristoffersen@ntnu.no.
authors.forename: Laila
authors.initials: L
authors.lastname: Kristoffersen
authors.affiliation: Department of Pediatrics, St. Olav's University Hospital, Trondheim, Norway.|Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
authors.forename: Ragnhild
authors.initials: R
authors.lastname: Støen
authors.affiliation: Department of Pediatrics, St. Olav's University Hospital, Trondheim, Norway.
authors.forename: Hilde
authors.initials: H
authors.lastname: Rygh
authors.affiliation: Department of Clinical Services, St. Olav's University Hospital, Trondheim, Norway.
authors.forename: Margunn
authors.initials: M
authors.lastname: Sognnæs
authors.affiliation: Department of Public Health and General Practice, NTNU, Trondheim, Norway.
authors.forename: Turid
authors.initials: T
authors.lastname: Follestad
authors.affiliation: Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.|Department of Anesthesia and Intensive Care Medicine, St. Olav's University Hospital, Trondheim, Norway.
authors.forename: Hilde S
authors.initials: HS
authors.lastname: Mohn
authors.affiliation: Department of Pediatrics, St. Olav's University Hospital, Trondheim, Norway.|Department of Anesthesia and Intensive Care Medicine, St. Olav's University Hospital, Trondheim, Norway.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Nissen
authors.affiliation: Department of Pediatrics, St. Olav's University Hospital, Trondheim, Norway.|Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.
authors.forename: Håkon
authors.initials: H
authors.lastname: Bergseng
mesh_terms: D001724:Birth Weight; D057189:Checklist; D002657:Child Development; D002675:Child, Preschool; D002985:Clinical Protocols; D005865:Gestational Age; D006801:Humans; D007186:Incubators, Infant; D007223:Infant; D007230:Infant, Low Birth Weight / Q000523:psychology*; D007231:Infant, Newborn; D007234:Infant, Premature / Q000523:psychology*; D019102:Infant, Very Low Birth Weight / Q000523:psychology; D007363:Intensive Care Units, Neonatal; D060127:Kangaroo-Mother Care Method; D009034:Mother-Child Relations; D009664:Norway; D009769:Object Attachment; D012107:Research Design; D012879:Skin Physiological Phenomena; D013997:Time Factors; D057188:Workflow
keywords: Early skin-to-skin; Kangaroo mother care; Neonatal intensive care unit; Very preterm infants