Open Access Study protocol

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

Fernando Althabe1, José M Belizán1, Agustina Mazzoni1*, Mabel Berrueta1, Jay Hemingway-Foday2, Marion Koso-Thomas3, Elizabeth McClure4, Elwyn Chomba5, Ana Garces6, Shivaprasad Goudar78, Bhalchandra Kodkany9, Sarah Saleem10, Omrana Pasha10, Archana Patel11, Fabian Esamai12, Waldemar A Carlo13, Nancy F Krebs14, Richard J Derman15, Robert L Goldenberg16, Patricia Hibberd17, Edward A Liechty18, Linda L Wright19, Eduardo F Bergel1, Alan H Jobe20 and Pierre Buekens21

Author Affiliations

1 Institute for Clinical Effectiveness and Health Policy (IECS), Dr. Emilio Ravignani 2024, Buenos Aires, C1414CPV, Argentina

2 RTI International, 3040 Cornwallis Rd, Cox 229, Research Triangle Park, NC, 27709, USA

3 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

4 RTI International, 3040 Cornwallis Rd, Hill 320, Durham, NC, 27709, USA

5 University Teaching Hospital, Lusaka, Zambia

6 IMSALUD, 3ra calle A 6-56 zona 10, oficina 207, Guatemala City, 01011, Guatemala

7 Department of Physiology, J N Medical College, Belgaum, Karnataka, 590 010, INDIA

8 Department of Medical Education, J N Medical College, Belgaum, Karnataka, 590 010, INDIA

9 KLEU Research Foundation, Jawaharlal Nehru Medical College, Belgaum, Karnataka, 590 010, INDIA

10 Departments of Community Health Sciences, Aga Khan University Medical College, PO Box 3500, Stadium Road, Karachi, 74800, Pakistan

11 Department of Pediatrics, Clinical Epidemiology Unit, Indira Gandhi Government Medical College, Opp Tidke Vidyalay, Katol Road, Nagpur, 440013, INDIA

12 Moi University School of Medicine, PO Box 3900, Eldoret, 30100, Kenya

13 Department of Pediatrics/Division of Neonatology, University of Alabama at Birmingham, 619 S 20th Street, 525 New Hillman, Birmingham, Alabama

14 Pediatric Nutrition, University of Colorado Denver, Box C225, Research Complex II, 12700 East 19th Avenue, Rm 5026, Aurora, CO, 80045, USA

15 Department of OB-GYN Christiana Care, 4755 Ogletown-Stanton Rd Room 1903, Newark, DE, 19718, USA

16 Department of Obstetrics/Gynecology, Columbia University, 622 West 168th Street, PH16, New York, NY, 10032, USA

17 Division of Global Health, Department of Pediatrics, Massachusetts General Hospital for Children, 50 Staniford Street, Suite 1054 125, Boston, MA, 02114, USA

18 Department of Pediatrics, Indiana University School of Medicine, 699 West Drive, RR 208, Indianapolis, IN, 46202-5119, USA

19 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

20 Cincinnati Childrens Hospital, 3333 Burnet Ave, Cincinnati, OH, 45229, USA

21 Tulane School of Public Health and Tropical Medicine, School of Public Health, 1440 Canal Street, Suite 2430, New Orleans, LA, 70112, USA

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Reproductive Health 2012, 9:22  doi:10.1186/1742-4755-9-22

Published: 19 September 2012

Abstract

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

Keywords:
Neonatal mortality; Antenatal corticosteroids; Implementation research; Preterm birth