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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
INTRODUCTION: In Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother’s warmth, nutrition and other benefits. Preterm infant...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342825/ https://www.ncbi.nlm.nih.gov/pubmed/32636292 http://dx.doi.org/10.1136/bmjopen-2020-038938 |
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author | Linnér, Agnes Westrup, Björn Lode-Kolz, Karoline Klemming, Stina Lillieskold, Siri Markhus Pike, Hanne Morgan, Barak Bergman, Nils Johannes Rettedal, Siren Jonas, Wibke |
author_facet | Linnér, Agnes Westrup, Björn Lode-Kolz, Karoline Klemming, Stina Lillieskold, Siri Markhus Pike, Hanne Morgan, Barak Bergman, Nils Johannes Rettedal, Siren Jonas, Wibke |
author_sort | Linnér, Agnes |
collection | PubMed |
description | INTRODUCTION: In Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother’s warmth, nutrition and other benefits. Preterm infants face health and neurodevelopment challenges that may also affect the family and society at large. There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth. METHODS AND ANALYSIS: In this ongoing randomised controlled trial from Stavanger, Norway and Stockholm, Sweden, we are studying 150 infants born at 28+0 to 32+6 gestational weeks, randomised to receive care immediately after birth in SSC with a parent or conventionally in an incubator. The primary outcome is cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score. Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health. ETHICS AND DISSEMINATION: The study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019–03361) and the Norwegian Regional Ethical Committee (2015/889). The study is conducted according to good clinical practice and the Helsinki declaration. The results of the study will increase the knowledge about the mechanisms behind the effects of SSC for very preterm infants by dissemination to the scientific community through articles and at conferences, and to the society through parenting classes and magazines. STUDY STATUS: Recruiting since April 2018. Expected trial termination June 2021. TRIAL REGISTRATION NUMBER: NCT03521310 (ClinicalTrials.gov). |
format | Online Article Text |
id | pubmed-7342825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-73428252020-07-09 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 Linnér, Agnes Westrup, Björn Lode-Kolz, Karoline Klemming, Stina Lillieskold, Siri Markhus Pike, Hanne Morgan, Barak Bergman, Nils Johannes Rettedal, Siren Jonas, Wibke BMJ Open Paediatrics INTRODUCTION: In Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother’s warmth, nutrition and other benefits. Preterm infants face health and neurodevelopment challenges that may also affect the family and society at large. There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth. METHODS AND ANALYSIS: In this ongoing randomised controlled trial from Stavanger, Norway and Stockholm, Sweden, we are studying 150 infants born at 28+0 to 32+6 gestational weeks, randomised to receive care immediately after birth in SSC with a parent or conventionally in an incubator. The primary outcome is cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score. Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health. ETHICS AND DISSEMINATION: The study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019–03361) and the Norwegian Regional Ethical Committee (2015/889). The study is conducted according to good clinical practice and the Helsinki declaration. The results of the study will increase the knowledge about the mechanisms behind the effects of SSC for very preterm infants by dissemination to the scientific community through articles and at conferences, and to the society through parenting classes and magazines. STUDY STATUS: Recruiting since April 2018. Expected trial termination June 2021. TRIAL REGISTRATION NUMBER: NCT03521310 (ClinicalTrials.gov). BMJ Publishing Group 2020-07-06 /pmc/articles/PMC7342825/ /pubmed/32636292 http://dx.doi.org/10.1136/bmjopen-2020-038938 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Paediatrics Linnér, Agnes Westrup, Björn Lode-Kolz, Karoline Klemming, Stina Lillieskold, Siri Markhus Pike, Hanne Morgan, Barak Bergman, Nils Johannes Rettedal, Siren Jonas, Wibke 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Paediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342825/ https://www.ncbi.nlm.nih.gov/pubmed/32636292 http://dx.doi.org/10.1136/bmjopen-2020-038938 |
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