A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-i...
- Autores
- Althabe, Fernando; Belizan, Jose; McClure, Elizabeth M.; Hemingway Foday, Jennifer; Berrueta, Amanda Mabel; Mazzoni, Agustina; Ciganda, Alvaro; Goudar, Shivaprasad S.; Kodkany, Bhalachandra S.; Mahantshetti, Niranjana S.; Dhaded, Sangappa M.; Katageri, Geetanjali M.; Metgud, Mrityunjay C.; Joshi, Anjali M.; Bellad, Mrutyunjaya B.; Honnungar, Narayan V.; Derman, Richard J.; Saleem, Sarah; Pasha, Omrana; Ali, Sumera; Hasnain, Farid; Goldenberg, Robert L; Esamai, Fabian; Nyongesa, Paul; Ayunga, Silas; Liechty, Edward A; Garces, Ana L; Figueroa, Lester; Hambidge, K Michael; Krebs, Nancy F; Patel, Archana; Bhandarkar, Anjali; Waikar, Manjushri; Hibberd, Patricia L; Chomba, Elwyn; Carlo, Waldemar A; Mwiche, Angel; Chiwila, Melody; Manasyan, Albert; Pineda, Sayury; Meleth, Sreelatha; Thorsten, Vanessa; Stolka, Kristen; Wallace, Dennis D; Koso-Thomas, Marion; Jobe, Alan H; Buekens, Pierre M
- Año de publicación
- 2015
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. Methods In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096. Findings The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47 394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50 743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48 219 women in the intervention group and 867 (2%) of 51 523 in the control group (OR 1·45, 1·33-1·58, p<0·0001). Interpretation Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: McClure, Elizabeth M.. No especifíca;
Fil: Hemingway Foday, Jennifer. No especifíca;
Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Goudar, Shivaprasad S.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Kodkany, Bhalachandra S.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Mahantshetti, Niranjana S.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Dhaded, Sangappa M.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Katageri, Geetanjali M.. S. Nijalingappa Medical College; India
Fil: Metgud, Mrityunjay C.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Joshi, Anjali M.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Bellad, Mrutyunjaya B.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Honnungar, Narayan V.. Jawaharlal Nehru Medical College Belgaum; India
Fil: Derman, Richard J.. Christiana Health Care Services; Estados Unidos
Fil: Saleem, Sarah. The Aga Khan University; Pakistán
Fil: Pasha, Omrana. The Aga Khan University; Pakistán
Fil: Ali, Sumera. The Aga Khan University; Pakistán
Fil: Hasnain, Farid. The Aga Khan University; Pakistán
Fil: Goldenberg, Robert L. Columbia University; Estados Unidos
Fil: Esamai, Fabian. Moi University; Kenia
Fil: Nyongesa, Paul. Moi University; Kenia
Fil: Ayunga, Silas. University of Alabama at Birmingahm; Estados Unidos
Fil: Liechty, Edward A. Indiana University; Estados Unidos
Fil: Garces, Ana L. Francisco Marroquin University; Guatemala. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala
Fil: Figueroa, Lester. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala
Fil: Hambidge, K Michael. State University of Colorado - Fort Collins; Estados Unidos
Fil: Krebs, Nancy F. State University of Colorado - Fort Collins; Estados Unidos
Fil: Patel, Archana. Government Medical College Nagpur; India. Lata Medical Research Foundation; India
Fil: Bhandarkar, Anjali. Lata Medical Research Foundation; India
Fil: Waikar, Manjushri. Lata Medical Research Foundation; India
Fil: Hibberd, Patricia L. Massachusetts General Hospital; Estados Unidos
Fil: Chomba, Elwyn. University Teaching Hospital Lusaka; Zambia
Fil: Carlo, Waldemar A. University of Alabama at Birmingahm; Estados Unidos
Fil: Mwiche, Angel. University Teaching Hospital Lusaka; Zambia
Fil: Chiwila, Melody. Centre For Infectious Disease Research; Zambia
Fil: Manasyan, Albert. University of Alabama at Birmingahm; Estados Unidos
Fil: Pineda, Sayury. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala
Fil: Meleth, Sreelatha. Rti International; Estados Unidos
Fil: Thorsten, Vanessa. Rti International; Estados Unidos
Fil: Stolka, Kristen. Rti International; Estados Unidos
Fil: Wallace, Dennis D. Rti International; Estados Unidos
Fil: Koso-Thomas, Marion. National Instituto Of Child Health & Human Developm.; Estados Unidos
Fil: Jobe, Alan H. Cincinnati Children's Hospital Medical Center; Estados Unidos
Fil: Buekens, Pierre M. Tulane University School Of Public Health And Tropical Medicine; Estados Unidos - Materia
- Neonatal Mortality
- Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/38318
Ver los metadatos del registro completo
| id |
CONICETDig_4830bd8092a1e2fdccad03e8e023d2db |
|---|---|
| oai_identifier_str |
oai:ri.conicet.gov.ar:11336/38318 |
| network_acronym_str |
CONICETDig |
| repository_id_str |
3498 |
| network_name_str |
CONICET Digital (CONICET) |
| spelling |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trialAlthabe, FernandoBelizan, JoseMcClure, Elizabeth M.Hemingway Foday, JenniferBerrueta, Amanda MabelMazzoni, AgustinaCiganda, AlvaroGoudar, Shivaprasad S.Kodkany, Bhalachandra S.Mahantshetti, Niranjana S.Dhaded, Sangappa M.Katageri, Geetanjali M.Metgud, Mrityunjay C.Joshi, Anjali M.Bellad, Mrutyunjaya B.Honnungar, Narayan V.Derman, Richard J.Saleem, SarahPasha, OmranaAli, SumeraHasnain, FaridGoldenberg, Robert LEsamai, FabianNyongesa, PaulAyunga, SilasLiechty, Edward AGarces, Ana LFigueroa, LesterHambidge, K MichaelKrebs, Nancy FPatel, ArchanaBhandarkar, AnjaliWaikar, ManjushriHibberd, Patricia LChomba, ElwynCarlo, Waldemar AMwiche, AngelChiwila, MelodyManasyan, AlbertPineda, SayuryMeleth, SreelathaThorsten, VanessaStolka, KristenWallace, Dennis DKoso-Thomas, MarionJobe, Alan HBuekens, Pierre MNeonatal Mortalityhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. Methods In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096. Findings The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47 394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50 743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48 219 women in the intervention group and 867 (2%) of 51 523 in the control group (OR 1·45, 1·33-1·58, p<0·0001). Interpretation Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development.Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: McClure, Elizabeth M.. No especifíca;Fil: Hemingway Foday, Jennifer. No especifíca;Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Goudar, Shivaprasad S.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Kodkany, Bhalachandra S.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Mahantshetti, Niranjana S.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Dhaded, Sangappa M.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Katageri, Geetanjali M.. S. Nijalingappa Medical College; IndiaFil: Metgud, Mrityunjay C.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Joshi, Anjali M.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Bellad, Mrutyunjaya B.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Honnungar, Narayan V.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Derman, Richard J.. Christiana Health Care Services; Estados UnidosFil: Saleem, Sarah. The Aga Khan University; PakistánFil: Pasha, Omrana. The Aga Khan University; PakistánFil: Ali, Sumera. The Aga Khan University; PakistánFil: Hasnain, Farid. The Aga Khan University; PakistánFil: Goldenberg, Robert L. Columbia University; Estados UnidosFil: Esamai, Fabian. Moi University; KeniaFil: Nyongesa, Paul. Moi University; KeniaFil: Ayunga, Silas. University of Alabama at Birmingahm; Estados UnidosFil: Liechty, Edward A. Indiana University; Estados UnidosFil: Garces, Ana L. Francisco Marroquin University; Guatemala. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; GuatemalaFil: Figueroa, Lester. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; GuatemalaFil: Hambidge, K Michael. State University of Colorado - Fort Collins; Estados UnidosFil: Krebs, Nancy F. State University of Colorado - Fort Collins; Estados UnidosFil: Patel, Archana. Government Medical College Nagpur; India. Lata Medical Research Foundation; IndiaFil: Bhandarkar, Anjali. Lata Medical Research Foundation; IndiaFil: Waikar, Manjushri. Lata Medical Research Foundation; IndiaFil: Hibberd, Patricia L. Massachusetts General Hospital; Estados UnidosFil: Chomba, Elwyn. University Teaching Hospital Lusaka; ZambiaFil: Carlo, Waldemar A. University of Alabama at Birmingahm; Estados UnidosFil: Mwiche, Angel. University Teaching Hospital Lusaka; ZambiaFil: Chiwila, Melody. Centre For Infectious Disease Research; ZambiaFil: Manasyan, Albert. University of Alabama at Birmingahm; Estados UnidosFil: Pineda, Sayury. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; GuatemalaFil: Meleth, Sreelatha. Rti International; Estados UnidosFil: Thorsten, Vanessa. Rti International; Estados UnidosFil: Stolka, Kristen. Rti International; Estados UnidosFil: Wallace, Dennis D. Rti International; Estados UnidosFil: Koso-Thomas, Marion. National Instituto Of Child Health & Human Developm.; Estados UnidosFil: Jobe, Alan H. Cincinnati Children's Hospital Medical Center; Estados UnidosFil: Buekens, Pierre M. Tulane University School Of Public Health And Tropical Medicine; Estados UnidosElsevier Science Inc2015-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/pdfhttp://hdl.handle.net/11336/38318Althabe, Fernando; Belizan, Jose; McClure, Elizabeth M.; Hemingway Foday, Jennifer; Berrueta, Amanda Mabel; et al.; A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial; Elsevier Science Inc; Lancet; 385; 9968; 2-2015; 629-6390140-6736CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/S0140-6736(14)61651-2info:eu-repo/semantics/altIdentifier/url/http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61651-2/abstractinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:03:09Zoai:ri.conicet.gov.ar:11336/38318instacron: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:34982025-09-03 10:03:10.028CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
| dc.title.none.fl_str_mv |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| title |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| spellingShingle |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial Althabe, Fernando Neonatal Mortality |
| title_short |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| title_full |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| title_fullStr |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| title_full_unstemmed |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| title_sort |
A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial |
| dc.creator.none.fl_str_mv |
Althabe, Fernando Belizan, Jose McClure, Elizabeth M. Hemingway Foday, Jennifer Berrueta, Amanda Mabel Mazzoni, Agustina Ciganda, Alvaro Goudar, Shivaprasad S. Kodkany, Bhalachandra S. Mahantshetti, Niranjana S. Dhaded, Sangappa M. Katageri, Geetanjali M. Metgud, Mrityunjay C. Joshi, Anjali M. Bellad, Mrutyunjaya B. Honnungar, Narayan V. Derman, Richard J. Saleem, Sarah Pasha, Omrana Ali, Sumera Hasnain, Farid Goldenberg, Robert L Esamai, Fabian Nyongesa, Paul Ayunga, Silas Liechty, Edward A Garces, Ana L Figueroa, Lester Hambidge, K Michael Krebs, Nancy F Patel, Archana Bhandarkar, Anjali Waikar, Manjushri Hibberd, Patricia L Chomba, Elwyn Carlo, Waldemar A Mwiche, Angel Chiwila, Melody Manasyan, Albert Pineda, Sayury Meleth, Sreelatha Thorsten, Vanessa Stolka, Kristen Wallace, Dennis D Koso-Thomas, Marion Jobe, Alan H Buekens, Pierre M |
| author |
Althabe, Fernando |
| author_facet |
Althabe, Fernando Belizan, Jose McClure, Elizabeth M. Hemingway Foday, Jennifer Berrueta, Amanda Mabel Mazzoni, Agustina Ciganda, Alvaro Goudar, Shivaprasad S. Kodkany, Bhalachandra S. Mahantshetti, Niranjana S. Dhaded, Sangappa M. Katageri, Geetanjali M. Metgud, Mrityunjay C. Joshi, Anjali M. Bellad, Mrutyunjaya B. Honnungar, Narayan V. Derman, Richard J. Saleem, Sarah Pasha, Omrana Ali, Sumera Hasnain, Farid Goldenberg, Robert L Esamai, Fabian Nyongesa, Paul Ayunga, Silas Liechty, Edward A Garces, Ana L Figueroa, Lester Hambidge, K Michael Krebs, Nancy F Patel, Archana Bhandarkar, Anjali Waikar, Manjushri Hibberd, Patricia L Chomba, Elwyn Carlo, Waldemar A Mwiche, Angel Chiwila, Melody Manasyan, Albert Pineda, Sayury Meleth, Sreelatha Thorsten, Vanessa Stolka, Kristen Wallace, Dennis D Koso-Thomas, Marion Jobe, Alan H Buekens, Pierre M |
| author_role |
author |
| author2 |
Belizan, Jose McClure, Elizabeth M. Hemingway Foday, Jennifer Berrueta, Amanda Mabel Mazzoni, Agustina Ciganda, Alvaro Goudar, Shivaprasad S. Kodkany, Bhalachandra S. Mahantshetti, Niranjana S. Dhaded, Sangappa M. Katageri, Geetanjali M. Metgud, Mrityunjay C. Joshi, Anjali M. Bellad, Mrutyunjaya B. Honnungar, Narayan V. Derman, Richard J. Saleem, Sarah Pasha, Omrana Ali, Sumera Hasnain, Farid Goldenberg, Robert L Esamai, Fabian Nyongesa, Paul Ayunga, Silas Liechty, Edward A Garces, Ana L Figueroa, Lester Hambidge, K Michael Krebs, Nancy F Patel, Archana Bhandarkar, Anjali Waikar, Manjushri Hibberd, Patricia L Chomba, Elwyn Carlo, Waldemar A Mwiche, Angel Chiwila, Melody Manasyan, Albert Pineda, Sayury Meleth, Sreelatha Thorsten, Vanessa Stolka, Kristen Wallace, Dennis D Koso-Thomas, Marion Jobe, Alan H Buekens, Pierre M |
| 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 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 |
Neonatal Mortality |
| topic |
Neonatal Mortality |
| purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3 |
| dc.description.none.fl_txt_mv |
Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. Methods In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096. Findings The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47 394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50 743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48 219 women in the intervention group and 867 (2%) of 51 523 in the control group (OR 1·45, 1·33-1·58, p<0·0001). Interpretation Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development. Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: McClure, Elizabeth M.. No especifíca; Fil: Hemingway Foday, Jennifer. No especifíca; Fil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Goudar, Shivaprasad S.. Jawaharlal Nehru Medical College Belgaum; India Fil: Kodkany, Bhalachandra S.. Jawaharlal Nehru Medical College Belgaum; India Fil: Mahantshetti, Niranjana S.. Jawaharlal Nehru Medical College Belgaum; India Fil: Dhaded, Sangappa M.. Jawaharlal Nehru Medical College Belgaum; India Fil: Katageri, Geetanjali M.. S. Nijalingappa Medical College; India Fil: Metgud, Mrityunjay C.. Jawaharlal Nehru Medical College Belgaum; India Fil: Joshi, Anjali M.. Jawaharlal Nehru Medical College Belgaum; India Fil: Bellad, Mrutyunjaya B.. Jawaharlal Nehru Medical College Belgaum; India Fil: Honnungar, Narayan V.. Jawaharlal Nehru Medical College Belgaum; India Fil: Derman, Richard J.. Christiana Health Care Services; Estados Unidos Fil: Saleem, Sarah. The Aga Khan University; Pakistán Fil: Pasha, Omrana. The Aga Khan University; Pakistán Fil: Ali, Sumera. The Aga Khan University; Pakistán Fil: Hasnain, Farid. The Aga Khan University; Pakistán Fil: Goldenberg, Robert L. Columbia University; Estados Unidos Fil: Esamai, Fabian. Moi University; Kenia Fil: Nyongesa, Paul. Moi University; Kenia Fil: Ayunga, Silas. University of Alabama at Birmingahm; Estados Unidos Fil: Liechty, Edward A. Indiana University; Estados Unidos Fil: Garces, Ana L. Francisco Marroquin University; Guatemala. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala Fil: Figueroa, Lester. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala Fil: Hambidge, K Michael. State University of Colorado - Fort Collins; Estados Unidos Fil: Krebs, Nancy F. State University of Colorado - Fort Collins; Estados Unidos Fil: Patel, Archana. Government Medical College Nagpur; India. Lata Medical Research Foundation; India Fil: Bhandarkar, Anjali. Lata Medical Research Foundation; India Fil: Waikar, Manjushri. Lata Medical Research Foundation; India Fil: Hibberd, Patricia L. Massachusetts General Hospital; Estados Unidos Fil: Chomba, Elwyn. University Teaching Hospital Lusaka; Zambia Fil: Carlo, Waldemar A. University of Alabama at Birmingahm; Estados Unidos Fil: Mwiche, Angel. University Teaching Hospital Lusaka; Zambia Fil: Chiwila, Melody. Centre For Infectious Disease Research; Zambia Fil: Manasyan, Albert. University of Alabama at Birmingahm; Estados Unidos Fil: Pineda, Sayury. Fundacion Para la Alimentacion y Nutricion de Centro America y Panama; Guatemala Fil: Meleth, Sreelatha. Rti International; Estados Unidos Fil: Thorsten, Vanessa. Rti International; Estados Unidos Fil: Stolka, Kristen. Rti International; Estados Unidos Fil: Wallace, Dennis D. Rti International; Estados Unidos Fil: Koso-Thomas, Marion. National Instituto Of Child Health & Human Developm.; Estados Unidos Fil: Jobe, Alan H. Cincinnati Children's Hospital Medical Center; Estados Unidos Fil: Buekens, Pierre M. Tulane University School Of Public Health And Tropical Medicine; Estados Unidos |
| description |
Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. Methods In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096. Findings The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47 394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50 743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48 219 women in the intervention group and 867 (2%) of 51 523 in the control group (OR 1·45, 1·33-1·58, p<0·0001). Interpretation Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development. |
| publishDate |
2015 |
| dc.date.none.fl_str_mv |
2015-02 |
| 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/11336/38318 Althabe, Fernando; Belizan, Jose; McClure, Elizabeth M.; Hemingway Foday, Jennifer; Berrueta, Amanda Mabel; et al.; A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial; Elsevier Science Inc; Lancet; 385; 9968; 2-2015; 629-639 0140-6736 CONICET Digital CONICET |
| url |
http://hdl.handle.net/11336/38318 |
| identifier_str_mv |
Althabe, Fernando; Belizan, Jose; McClure, Elizabeth M.; Hemingway Foday, Jennifer; Berrueta, Amanda Mabel; et al.; A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: The ACT cluster-randomised trial; Elsevier Science Inc; Lancet; 385; 9968; 2-2015; 629-639 0140-6736 CONICET Digital CONICET |
| dc.language.none.fl_str_mv |
eng |
| language |
eng |
| dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/doi/10.1016/S0140-6736(14)61651-2 info:eu-repo/semantics/altIdentifier/url/http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61651-2/abstract |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
| eu_rights_str_mv |
openAccess |
| rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
| dc.format.none.fl_str_mv |
application/pdf application/vnd.openxmlformats-officedocument.wordprocessingml.document application/pdf |
| dc.publisher.none.fl_str_mv |
Elsevier Science Inc |
| publisher.none.fl_str_mv |
Elsevier Science Inc |
| 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 |
| _version_ |
1842269785580109824 |
| score |
13.13397 |