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

Reproductive Health

Pierre Buekens^1,10  Alan H Jobe⁶  Eduardo F Bergel^1,12  Linda L Wright^1,11  Edward A Liechty^1,13  Patricia Hibberd^1,16  Robert L Goldenberg^1,19  Richard J Derman⁹  Nancy F Krebs^2,20  Waldemar A Carlo^1,14  Fabian Esamai¹  Archana Patel⁴  Omrana Pasha^1,18  Sarah Saleem^1,18  Bhalchandra Kodkany²  Shivaprasad Goudar^1,15  Ana Garces⁸  Elwyn Chomba⁵  Elizabeth McClure³  Marion Koso-Thomas⁷  Jay Hemingway-Foday^1,17  Mabel Berrueta^1,12  Agustina Mazzoni^1,12  José M Belizán^1,12  Fernando Althabe^1,12 

[1] Moi University School of Medicine, PO Box 3900, Eldoret, 30100, Kenya;KLEU Research Foundation, Jawaharlal Nehru Medical College, Belgaum, Karnataka, 590 010, INDIA;RTI International, 3040 Cornwallis Rd, Hill 320, Durham, NC, 27709, USA;Department of Pediatrics, Clinical Epidemiology Unit, Indira Gandhi Government Medical College, Opp Tidke Vidyalay, Katol Road, Nagpur, 440013, INDIA;University Teaching Hospital, Lusaka, Zambia;Cincinnati Childrens Hospital, 3333 Burnet Ave, Cincinnati, OH, 45229, USA;Center for Research for Mothers and Children Eunice Kennedy Shriver, National Institute of Child Health and Human Development. National Institutes of Health, 6100 Executive Blvd, Room 4B09B, MSC 7510, Rockville, MD, 20852-7510, USA;IMSALUD, 3ra calle A 6-56 zona 10, oficina 207, Guatemala City, 01011, Guatemala;Department of OB-GYN Christiana Care, 4755 Ogletown-Stanton Rd Room 1903, Newark, DE, 19718, USA;Tulane School of Public Health and Tropical Medicine, School of Public Health, 1440 Canal Street, Suite 2430, New Orleans, LA, 70112, USA;Center for Research of Mothers and Children, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Blvd., Room 4B05J, MSC 7510, Rockville, MD, 20852-7510, USA;Institute for Clinical Effectiveness and Health Policy (IECS), Dr. Emilio Ravignani 2024, Buenos Aires, C1414CPV, Argentina;Department of Pediatrics, Indiana University School of Medicine, 699 West Drive, RR 208, Indianapolis, IN, 46202-5119, USA;Department of Pediatrics/Division of Neonatology, University of Alabama at Birmingham, 619 S 20th Street, 525 New Hillman, Birmingham, Alabama;Department of Medical Education, J N Medical College, Belgaum, Karnataka, 590 010, INDIA;Division of Global Health, Department of Pediatrics, Massachusetts General Hospital for Children, 50 Staniford Street, Suite 1054 125, Boston, MA, 02114, USA;RTI International, 3040 Cornwallis Rd, Cox 229, Research Triangle Park, NC, 27709, USA;Departments of Community Health Sciences, Aga Khan University Medical College, PO Box 3500, Stadium Road, Karachi, 74800, Pakistan;Department of Obstetrics/Gynecology, Columbia University, 622 West 168th Street, PH16, New York, NY, 10032, USA;Pediatric Nutrition, University of Colorado Denver, Box C225, Research Complex II, 12700 East 19th Avenue, Rm 5026, Aurora, CO, 80045, USA

关键词: Preterm birth;    Implementation research;    Antenatal corticosteroids;    Neonatal mortality;   

Others  :  812057
DOI  :  10.1186/1742-4755-9-22

 received in 2012-09-01, accepted in 2012-09-12,  发布年份 2012

【 摘 要 】

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

ClinicalTrials.gov. Identifier: NCT01084096

【 授权许可】

   
2012 Althabe et al.; licensee BioMed Central Ltd.

【 图 表 】

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