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

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• 作者：Fernando Althabe (1)
  José M Belizán (1)
  Agustina Mazzoni (1)
  Mabel Berrueta (1)
  Jay Hemingway-Foday (2)
  Marion Koso-Thomas (3)
  Elizabeth McClure (4)
  Elwyn Chomba (5)
  Ana Garces (6)
  Shivaprasad Goudar (7) (8)
  Bhalchandra Kodkany (9)
  Sarah Saleem (10)
  Omrana Pasha (10)
  Archana Patel (11)
  Fabian Esamai (12)
  Waldemar A Carlo (13)
  Nancy F Krebs (14)
  Richard J Derman (15)
  Robert L Goldenberg (16)
  Patricia Hibberd (17)
  Edward A Liechty (18)
  Linda L Wright (19)
  Eduardo F Bergel (1)
  Alan H Jobe (20)
  Pierre Buekens (21)
  
• 关键词：Neonatal mortality ; Antenatal corticosteroids ; Implementation research ; Preterm birth
• 刊名：Reproductive Health
• 出版年：2012
• 出版时间：December 2012
• 年：2012
• 卷：9
• 期：1
• 全文大小：851KB
• 参考文献：1. United Nations Millennium Declaration: / United Nations General Assembly Resolution 55/2. United Nations, New York, NY; 2000. Available at: http://www.un.org/millennium/declaration/ares552e.pdf. Accessed December 28, 2005
  2. Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L, for the Lancet Neonatal Survival Steering Team: Neonatal Survival 2: Evidence-based, cost-effective interventions: how many newborn babies can we save? / Lancet 2005, 365:977-88. CrossRef
  3. National Institutes of Health: consensus development conference statement. / The Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes 1994. Available at: 2005. http://consensus.nih.gov/1994/1994AntenatalSteroidPerinatal095html.htm. Accessed December 28, 2005
  4. Roberts D, Dalziel S: Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. / Cochrane Database of Systematic Reviews 2006., (3):
  5. Lawn JE, Cousens S, Zupan J, for the Lancet Neonatal Survival Steering Team: Neonatal Survival 1. 4 million neonatal deaths: When? Where? Why? / Lancet 2005, 365:891-00. CrossRef
  6. Harding JE, Pang J, Knight DB, Liggins GC: Do antenatal corticosteroids help in the setting of preterm rupture of membranes? / Am J Obstet Gynecol 2001,184(2):131-. CrossRef
  7. Gortner L, Wauer RR, Hammer H, Stock GJ, Heitmann F, Reiter HL, Kuhl PG, Moller JC, Friedrich HJ, Reiss I, Hentschel R, Jorch G, Hieronimi G, Kuhls E: Early versus late surfactant treatment in preterm infants of 27 to 32 weeks-gestational age: a multicenter controlled clinical trial. / Pediatrics 1998,102(5):1153-0. CrossRef
  8. Horbar JD, Badger GJ, Carpenter JH, Fanaroff AA, Kilpatrick S, LaCorte M, Phibbs R, Soll RF, Members of the Vermont Oxford Network: Trends in mortality and morbidity for very low birth weight infants, 1991-999. / Pediatrics 2002, 110:143-1. CrossRef
  9. Jones G, Steketee R, Black RE, The Bellagio Child Survival Study Group: How many child deaths can we prevent this year? / Lancet 2003, 362:65-1. CrossRef
  10. Krauss Silva L, Pinheiro T, Franklin R, Oliveira N: Assessment of quality of obstetric care and corticoid use in preterm labor. / Cadernos de Salude Publica 1999,15(4):1-3.
  11. Vargas-Origel A, Leon Ramirez D, Zamora-Orozco J: Corticoesterides antenatales: Empleo y actitud del personal medico ginecoobstetra. / Ginecol Obstet Mex 2000, 68:291-5.
  12. Forteza C, Díaz Rossello JL, Matijasevich A, Barros F: Morbidity and mortality of very low birth weight (VLBW) infants in Montevideo, Uruguay. Abstracts from the XXXIX Annual Meeting of the Latin American Society for Pediatric Research. Colonia del Sacramento, Uruguay, Nov. 2001. / Pediatr Res 2002,52(9):467.
  13. Vallejo Valdivieso N, Chinga Sampedro J, Sánchez Macías M, Tumbaco García R: Epidemiología del parto pretérmino y su repercusión en la morbi-mortalidad neonatal registrados en el hospital Dr. Verdi Cevallos Balda/Epidemiología of the childbirth preterm and its repercussion in neonative morbi-mortality registered in hospital Dr Verdi Cevallos. / Medicina (Guayaquil) 2002,8(1):36-1.
  14. Colomar M, Belizan M, Cafferata ML, Labandera A, Tomasso G, Althabe F, Belizan JM: Grupo de Estudio de Practicas Perinatales [Practices of maternal and perinatal care performed in public hospitals of Uruguay]. / Ginecol Obstet Mex 2004, 72:455-5.
  15. Riganti AA, / et al.: Use of prenatal corticosteroids for preterm birth in three Latin American countries. / Int J Gynecol Obstet 2009.
  16. Goudar SS, / et al.: The maternal and newborn health registry study of the global network for women's and children's health research. / Int J Gynecol Obstet 2012.
  17. Treasure T, MacRae KD: Minimization is much better than the randomized block design in certain cases. / BMJ 1999, 318:263-. CrossRef
  18. Pasha O, Goldenberg RL, McClure EM, Saleem S, Goudar SS, Althabe F, Patel A, Esamai F, Garces A, Chomba E, Mazariegos M, Kodkany B, Belizan JM, Derman RJ, Hibberd PL, Carlo WA, Liechty EA, Hambidge KM, Buekens P, Wallace D, Howard-Grabman L, Stalls S, Koso-Thomas M, Jobe AH, Wright LL: Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the Global Network's EmONC trial). / BMC Pregnancy Childbirth 2010, 10:82. CrossRef
  19. World Health Organisation: Department of reproductive health and research, family and community health. / Integrated Management of Pregnancy and Childbirth 2003.
  20. Carlo WA, Goudar SS, Jehan I, / et al.: Newborn care training and perinatal mortality in communities in developing countries. / N Engl J Med 2010, 362:7. CrossRef
  21. Liang KY, Zeger SL: Longitudinal data analysis using generalized linear models. / Biometrika 1986,73(1):13-2. CrossRef
  
• 作者单位：Fernando Althabe (1)
  José M Belizán (1)
  Agustina Mazzoni (1)
  Mabel Berrueta (1)
  Jay Hemingway-Foday (2)
  Marion Koso-Thomas (3)
  Elizabeth McClure (4)
  Elwyn Chomba (5)
  Ana Garces (6)
  Shivaprasad Goudar (7) (8)
  Bhalchandra Kodkany (9)
  Sarah Saleem (10)
  Omrana Pasha (10)
  Archana Patel (11)
  Fabian Esamai (12)
  Waldemar A Carlo (13)
  Nancy F Krebs (14)
  Richard J Derman (15)
  Robert L Goldenberg (16)
  Patricia Hibberd (17)
  Edward A Liechty (18)
  Linda L Wright (19)
  Eduardo F Bergel (1)
  Alan H Jobe (20)
  Pierre Buekens (21)
  
  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
  

文摘

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