Cargando…
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...
Autores principales: | , , , , , , , |
---|---|
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 |
_version_ | 1782474769259560960 |
---|---|
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. |
format | Online Article Text |
id | pubmed-5153813 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT kristoffersenlaila earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT støenragnhild earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT ryghhilde earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT sognnæsmargunn earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT follestadturid earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT mohnhildes earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT nisseningrid earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial AT bergsenghakon earlyskintoskincontactorincubatorforverypreterminfantsstudyprotocolforarandomizedcontrolledtrial |