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Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial

BACKGROUND: 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 w...

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Autores principales: Kristoffersen, Laila, Støen, Ragnhild, Rygh, Hilde, Sognnæs, Margunn, Follestad, Turid, Mohn, Hilde S., Nissen, Ingrid, Bergseng, Håkon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153813/
https://www.ncbi.nlm.nih.gov/pubmed/27955652
http://dx.doi.org/10.1186/s13063-016-1730-5
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author Kristoffersen, Laila
Støen, Ragnhild
Rygh, Hilde
Sognnæs, Margunn
Follestad, Turid
Mohn, Hilde S.
Nissen, Ingrid
Bergseng, Håkon
author_facet Kristoffersen, Laila
Støen, Ragnhild
Rygh, Hilde
Sognnæs, Margunn
Follestad, Turid
Mohn, Hilde S.
Nissen, Ingrid
Bergseng, Håkon
author_sort Kristoffersen, Laila
collection PubMed
description BACKGROUND: 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. METHODS/DESIGN: A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 28(0)–31(6) weeks 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials, NCT02024854. Registered on 19 December 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1730-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-51538132016-12-20 Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial Kristoffersen, Laila Støen, Ragnhild Rygh, Hilde Sognnæs, Margunn Follestad, Turid Mohn, Hilde S. Nissen, Ingrid Bergseng, Håkon Trials Study Protocol BACKGROUND: 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. METHODS/DESIGN: A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 28(0)–31(6) weeks 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials, NCT02024854. Registered on 19 December 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1730-5) contains supplementary material, which is available to authorized users. BioMed Central 2016-12-12 /pmc/articles/PMC5153813/ /pubmed/27955652 http://dx.doi.org/10.1186/s13063-016-1730-5 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kristoffersen, Laila
Støen, Ragnhild
Rygh, Hilde
Sognnæs, Margunn
Follestad, Turid
Mohn, Hilde S.
Nissen, Ingrid
Bergseng, Håkon
Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title_full Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title_fullStr Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title_full_unstemmed Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title_short Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
title_sort early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153813/
https://www.ncbi.nlm.nih.gov/pubmed/27955652
http://dx.doi.org/10.1186/s13063-016-1730-5
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