Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol

Autores
Althabe, Fernando; Belizán, José M.; Mazzoni, Agustina; Berrueta, Mabel; Hemingway Foday, Jay; Koso-Thomas, Marion; McClure, Elizabeth; Chomba, Elwyn; Garces, Ana; Goudar, Shivaprasad; Kodkany, Bhalchandra; Saleem, Sarah; Pasha, Omrana; Patel, Archana; Esamai, Fabian; Carlo, Waldemar A.; Krebs, Nancy F.; Derman, Richard J.; Goldenberg, Robert L.; Hibberd, Patricia; Liechty, Edward A.; Wright, Linda L.; Bergel, Eduardo F.; Jobe, Alan H.; Buekens, Pierre
Año de publicación
2012
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods. We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration.
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Belizán, José M.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Hemingway Foday, Jay. No especifíca;
Fil: Koso-Thomas, Marion. National Institutes of Health; Estados Unidos
Fil: McClure, Elizabeth. No especifíca;
Fil: Chomba, Elwyn. No especifíca;
Fil: Garces, Ana. No especifíca;
Fil: Goudar, Shivaprasad. No especifíca;
Fil: Kodkany, Bhalchandra. No especifíca;
Fil: Saleem, Sarah. No especifíca;
Fil: Pasha, Omrana. No especifíca;
Fil: Patel, Archana. No especifíca;
Fil: Esamai, Fabian. No especifíca;
Fil: Carlo, Waldemar A.. No especifíca;
Fil: Krebs, Nancy F.. No especifíca;
Fil: Derman, Richard J.. No especifíca;
Fil: Goldenberg, Robert L.. No especifíca;
Fil: Hibberd, Patricia. No especifíca;
Fil: Liechty, Edward A.. No especifíca;
Fil: Wright, Linda L.. National Instituto of Child Health & Human Development; Estados Unidos
Fil: Bergel, Eduardo F.. No especifíca;
Fil: Jobe, Alan H.. No especifíca;
Fil: Buekens, Pierre. No especifíca;
Materia
ANTENATAL CORTICOSTEROIDS
IMPLEMENTATION RESEARCH
NEONATAL MORTALITY
PRETERM BIRTH
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/197970

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network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocolAlthabe, FernandoBelizán, José M.Mazzoni, AgustinaBerrueta, MabelHemingway Foday, JayKoso-Thomas, MarionMcClure, ElizabethChomba, ElwynGarces, AnaGoudar, ShivaprasadKodkany, BhalchandraSaleem, SarahPasha, OmranaPatel, ArchanaEsamai, FabianCarlo, Waldemar A.Krebs, Nancy F.Derman, Richard J.Goldenberg, Robert L.Hibberd, PatriciaLiechty, Edward A.Wright, Linda L.Bergel, Eduardo F.Jobe, Alan H.Buekens, PierreANTENATAL CORTICOSTEROIDSIMPLEMENTATION RESEARCHNEONATAL MORTALITYPRETERM BIRTHhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods. We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration.Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Belizán, José M.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Hemingway Foday, Jay. No especifíca;Fil: Koso-Thomas, Marion. National Institutes of Health; Estados UnidosFil: McClure, Elizabeth. No especifíca;Fil: Chomba, Elwyn. No especifíca;Fil: Garces, Ana. No especifíca;Fil: Goudar, Shivaprasad. No especifíca;Fil: Kodkany, Bhalchandra. No especifíca;Fil: Saleem, Sarah. No especifíca;Fil: Pasha, Omrana. No especifíca;Fil: Patel, Archana. No especifíca;Fil: Esamai, Fabian. No especifíca;Fil: Carlo, Waldemar A.. No especifíca;Fil: Krebs, Nancy F.. No especifíca;Fil: Derman, Richard J.. No especifíca;Fil: Goldenberg, Robert L.. No especifíca;Fil: Hibberd, Patricia. No especifíca;Fil: Liechty, Edward A.. No especifíca;Fil: Wright, Linda L.. National Instituto of Child Health & Human Development; Estados UnidosFil: Bergel, Eduardo F.. No especifíca;Fil: Jobe, Alan H.. No especifíca;Fil: Buekens, Pierre. No especifíca;BioMed Central2012-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/197970Althabe, Fernando; Belizán, José M.; Mazzoni, Agustina; Berrueta, Mabel; Hemingway Foday, Jay; et al.; Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol; BioMed Central; Reproductive Health Matters (print); 9; 1; 9-2012; 22-220968-80801742-4755CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-9-22info:eu-repo/semantics/altIdentifier/doi/10.1186/1742-4755-9-22info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:53:34Zoai:ri.conicet.gov.ar:11336/197970instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:53:34.747CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
title Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
spellingShingle Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
Althabe, Fernando
ANTENATAL CORTICOSTEROIDS
IMPLEMENTATION RESEARCH
NEONATAL MORTALITY
PRETERM BIRTH
title_short Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
title_full Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
title_fullStr Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
title_full_unstemmed Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
title_sort Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
dc.creator.none.fl_str_mv Althabe, Fernando
Belizán, José M.
Mazzoni, Agustina
Berrueta, Mabel
Hemingway Foday, Jay
Koso-Thomas, Marion
McClure, Elizabeth
Chomba, Elwyn
Garces, Ana
Goudar, Shivaprasad
Kodkany, Bhalchandra
Saleem, Sarah
Pasha, Omrana
Patel, Archana
Esamai, Fabian
Carlo, Waldemar A.
Krebs, Nancy F.
Derman, Richard J.
Goldenberg, Robert L.
Hibberd, Patricia
Liechty, Edward A.
Wright, Linda L.
Bergel, Eduardo F.
Jobe, Alan H.
Buekens, Pierre
author Althabe, Fernando
author_facet Althabe, Fernando
Belizán, José M.
Mazzoni, Agustina
Berrueta, Mabel
Hemingway Foday, Jay
Koso-Thomas, Marion
McClure, Elizabeth
Chomba, Elwyn
Garces, Ana
Goudar, Shivaprasad
Kodkany, Bhalchandra
Saleem, Sarah
Pasha, Omrana
Patel, Archana
Esamai, Fabian
Carlo, Waldemar A.
Krebs, Nancy F.
Derman, Richard J.
Goldenberg, Robert L.
Hibberd, Patricia
Liechty, Edward A.
Wright, Linda L.
Bergel, Eduardo F.
Jobe, Alan H.
Buekens, Pierre
author_role author
author2 Belizán, José M.
Mazzoni, Agustina
Berrueta, Mabel
Hemingway Foday, Jay
Koso-Thomas, Marion
McClure, Elizabeth
Chomba, Elwyn
Garces, Ana
Goudar, Shivaprasad
Kodkany, Bhalchandra
Saleem, Sarah
Pasha, Omrana
Patel, Archana
Esamai, Fabian
Carlo, Waldemar A.
Krebs, Nancy F.
Derman, Richard J.
Goldenberg, Robert L.
Hibberd, Patricia
Liechty, Edward A.
Wright, Linda L.
Bergel, Eduardo F.
Jobe, Alan H.
Buekens, Pierre
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv ANTENATAL CORTICOSTEROIDS
IMPLEMENTATION RESEARCH
NEONATAL MORTALITY
PRETERM BIRTH
topic ANTENATAL CORTICOSTEROIDS
IMPLEMENTATION RESEARCH
NEONATAL MORTALITY
PRETERM BIRTH
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods. We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration.
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Belizán, José M.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Hemingway Foday, Jay. No especifíca;
Fil: Koso-Thomas, Marion. National Institutes of Health; Estados Unidos
Fil: McClure, Elizabeth. No especifíca;
Fil: Chomba, Elwyn. No especifíca;
Fil: Garces, Ana. No especifíca;
Fil: Goudar, Shivaprasad. No especifíca;
Fil: Kodkany, Bhalchandra. No especifíca;
Fil: Saleem, Sarah. No especifíca;
Fil: Pasha, Omrana. No especifíca;
Fil: Patel, Archana. No especifíca;
Fil: Esamai, Fabian. No especifíca;
Fil: Carlo, Waldemar A.. No especifíca;
Fil: Krebs, Nancy F.. No especifíca;
Fil: Derman, Richard J.. No especifíca;
Fil: Goldenberg, Robert L.. No especifíca;
Fil: Hibberd, Patricia. No especifíca;
Fil: Liechty, Edward A.. No especifíca;
Fil: Wright, Linda L.. National Instituto of Child Health & Human Development; Estados Unidos
Fil: Bergel, Eduardo F.. No especifíca;
Fil: Jobe, Alan H.. No especifíca;
Fil: Buekens, Pierre. No especifíca;
description Background: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods. We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration.
publishDate 2012
dc.date.none.fl_str_mv 2012-09
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/197970
Althabe, Fernando; Belizán, José M.; Mazzoni, Agustina; Berrueta, Mabel; Hemingway Foday, Jay; et al.; Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol; BioMed Central; Reproductive Health Matters (print); 9; 1; 9-2012; 22-22
0968-8080
1742-4755
CONICET Digital
CONICET
url http://hdl.handle.net/11336/197970
identifier_str_mv Althabe, Fernando; Belizán, José M.; Mazzoni, Agustina; Berrueta, Mabel; Hemingway Foday, Jay; et al.; Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol; BioMed Central; Reproductive Health Matters (print); 9; 1; 9-2012; 22-22
0968-8080
1742-4755
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
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info:eu-repo/semantics/altIdentifier/doi/10.1186/1742-4755-9-22
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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