Neonatal Resuscitation in Developing Countries

Summary

Principal Investigator: Waldemar A Carlo
Affiliation: University of Alabama at Birmingham
Country: USA
Abstract: This application provides evidence that the proposed U.S. Principal Investigator has an established leadership record in the design, implementation, and publication of clinical trials, including several multicenter and single center trials. The assembled team consists of investigators highly qualified and motivated to perform the proposed work. A rigorously designed multicenter clinical trial of improved resuscitation to reduce mortality due to perinatal asphyxia is proposed. Perinatal asphyxia has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. In Zambia, perinatal asphyxia accounts for about 40% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from perinatal asphyxia, WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. Neonatal resuscitation is a simple, inexpensive, readily available, and cost effective intervention. Even though the principles of the Neonatal Resuscitation Program are recommended for international application, this successful U.S. program has had no dissemination in many developing countries including Zambia, and its effects on neonatal outcome have not been tested in a randomized controlled trial. The proposed randomized controlled trial will determine if implementation of the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to only basic perinatal care education of health care providers (Essential Newborn Care Program only) results in reduced mortality due to perinatal asphyxia. The trial will be performed in four cities in Zambia. The study design will assure validity, accuracy, and precision of the estimate of the treatment effects. If effective, further efforts to train healthcare workers worldwide in neonatal resuscitation could result in important reductions in perinatal mortality and morbidity. Improved neonatal resuscitation for newly born infants with perinatal asphyxia may be one of the most cost effective interventions in perinatal care. The proposed team of investigators will work with the NICHD and other centers of the Global Network for Women and Children's Health Research to design, prioritize, plan, implement, analyze, interpret, and report innovative randomized trials and observational studies that are likely to improve maternal and childhood survival and other important outcomes. The qualifications and unequivocal commitment of the U.S. Principal Investigator, the Senior Foreign Investigator, and the team of investigators, as well as the full endorsement of the Government of Zambia, the University of Zambia, and the University of Alabama at Birmingham will ensure superior performance if this application is funded.
Funding Period: 2003-09-26 - 2008-04-30
more information: NIH RePORT

Top Publications

  1. ncbi Stillbirth in developing countries
    E M McClure
    Statistics and Epidemiology, RTI International, Research Triangle Park, NC, USA
    Int J Gynaecol Obstet 94:82-90. 2006
  2. ncbi Evaluation of the educational impact of the WHO Essential Newborn Care course in Zambia
    E M McClure
    Research Triangle Institute, Durham, North Carolina 27709, USA
    Acta Paediatr 96:1135-8. 2007
  3. pmc The global network: a prospective study of stillbirths in developing countries
    Elizabeth M McClure
    Research Triangle Institute, Research Triangle Park, NC 27709, USA
    Am J Obstet Gynecol 197:247.e1-5. 2007
  4. pmc Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations
    Michele Bloch
    Tobacco Control Research Branch, National Cancer Institute, Executive Plaza North, Room 4038, 6130 Executive Blvd, MSC 7337, Bethesda, MD 20892 7337, USA
    Am J Public Health 98:1833-40. 2008
  5. pmc Effect of WHO newborn care training on neonatal mortality by education
    Elwyn Chomba
    Department of Paediatrics and Child Health, University of Zambia, Lusaka, Zambia
    Ambul Pediatr 8:300-4. 2008
  6. pmc Newborn-care training and perinatal mortality in developing countries
    Waldemar A Carlo
    University of Alabama at Birmingham, Birmingham, AL 35233, USA
    N Engl J Med 362:614-23. 2010

Detail Information

Publications6

  1. ncbi Stillbirth in developing countries
    E M McClure
    Statistics and Epidemiology, RTI International, Research Triangle Park, NC, USA
    Int J Gynaecol Obstet 94:82-90. 2006
    ..To conduct a systematic review of the literature on stillbirths in developing countries...
  2. ncbi Evaluation of the educational impact of the WHO Essential Newborn Care course in Zambia
    E M McClure
    Research Triangle Institute, Durham, North Carolina 27709, USA
    Acta Paediatr 96:1135-8. 2007
    ..To evaluate the effectiveness of the World Health Organization (WHO) Essential Newborn Care (ENC) course in improving knowledge and skills of nurse midwives in low-risk delivery clinics in a developing country...
  3. pmc The global network: a prospective study of stillbirths in developing countries
    Elizabeth M McClure
    Research Triangle Institute, Research Triangle Park, NC 27709, USA
    Am J Obstet Gynecol 197:247.e1-5. 2007
    ..Our goal was to determine stillbirth rates in a multisite population-based study in community settings in the developing world...
  4. pmc Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations
    Michele Bloch
    Tobacco Control Research Branch, National Cancer Institute, Executive Plaza North, Room 4038, 6130 Executive Blvd, MSC 7337, Bethesda, MD 20892 7337, USA
    Am J Public Health 98:1833-40. 2008
    ..We examined pregnant women's use of cigarettes and other tobacco products and the exposure of pregnant women and their young children to secondhand smoke (SHS) in 9 nations in Latin America, Asia, and Africa...
  5. pmc Effect of WHO newborn care training on neonatal mortality by education
    Elwyn Chomba
    Department of Paediatrics and Child Health, University of Zambia, Lusaka, Zambia
    Ambul Pediatr 8:300-4. 2008
    ....
  6. pmc Newborn-care training and perinatal mortality in developing countries
    Waldemar A Carlo
    University of Alabama at Birmingham, Birmingham, AL 35233, USA
    N Engl J Med 362:614-23. 2010
    ..Of the 3.7 million neonatal deaths and 3.3 million stillbirths each year, 98% occur in developing countries. An evaluation of community-based interventions designed to reduce the number of these deaths is needed...