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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/197970
Ver los metadatos del registro completo
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oai:ri.conicet.gov.ar:11336/197970 |
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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 |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/url/https://reproductive-health-journal.biomedcentral.com/articles/10.1186/1742-4755-9-22 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) |
collection |
CONICET Digital (CONICET) |
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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1844613635273392128 |
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13.070432 |