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Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol |
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| Authors: | Fernando Althabe José M Belizán Agustina Mazzoni Mabel Berrueta Jay Hemingway-Foday Marion Koso-Thomas Elizabeth McClure Elwyn Chomba Ana Garces Shivaprasad Goudar Bhalchandra Kodkany Sarah Saleem Omrana Pasha Archana Patel Fabian Esamai Waldemar A Carlo Nancy F Krebs Richard J Derman Robert L Goldenberg Patricia Hibberd Edward A Liechty Linda L Wright Eduardo F Bergel Alan H Jobe Pierre Buekens |
| Affiliation: | 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 |
| Abstract: | BackgroundPreterm 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.MethodsWe 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 registrationClinicalTrials.gov. Identifier: NCT01084096 |
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