Neonatal Resuscitation in Developing Countries

Summary

Principal Investigator: Waldemar A Carlo
Affiliation: University of Alabama at Birmingham
Country: USA
Abstract: DESCRIPTION (provided by applicant): 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. pmc Developmental trajectories of children with birth asphyxia through 36 months of age in low/low-middle income countries
    Jan L Wallander
    University of California, Merced, Merced, CA, United States Electronic address
    Early Hum Dev 90:343-8. 2014
  2. doi Neonatal death in low- to middle-income countries: a global network study
    Jose M Belizan
    Institute for Clinical Effectiveness, Buenos Aires, Argentina
    Am J Perinatol 29:649-56. 2012
  3. pmc The Maternal and Newborn Health Registry Study of the Global Network for Women's and Children's Health Research
    Shivaprasad S Goudar
    Department of Medical Education, Jawaharlal Nehru Medical College, Belgaum, India
    Int J Gynaecol Obstet 118:190-3. 2012
  4. pmc Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings
    Nancy F Krebs
    Department of Pediatrics, Section of Nutrition, University of Colorado Denver, Aurora, CO 80045, USA
    Am J Clin Nutr 96:840-7. 2012
  5. pmc Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries
    Waldemar A Carlo
    University of Alabama at Birmingham, Birmingham, AL Center for Infectious Disease Research in Zambia, Lusaka, Zambia
    J Pediatr 162:705-712.e3. 2013
  6. pmc Assessment of obstetric and neonatal health services in developing country health facilities
    Albert Manasyan
    Centre for Infectious Disease Zambia, Lusaka, Zambia
    Am J Perinatol 30:787-94. 2013
  7. pmc Plastic bags for prevention of hypothermia in preterm and low birth weight infants
    Alicia E Leadford
    University of Alabama at Birmingham, Birmingham, AL 35249 7335, USA
    Pediatrics 132:e128-34. 2013
  8. pmc Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting
    Theodore C Belsches
    Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA
    Pediatrics 132:e656-61. 2013
  9. pmc A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial
    Omrana Pasha
    Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan
    BMC Med 11:215. 2013
  10. pmc First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings
    Elizabeth M McClure
    Department of Statistics and Epidemiology, RTI International, Durham, NC, USA
    BMC Pregnancy Childbirth 14:73. 2014

Scientific Experts

  • W A Carlo
  • Elizabeth M McClure
  • Jan L Wallander
  • Shivaprasad S Goudar
  • C Engmann
  • K Hambidge
  • Nancy Krebs
  • Michele Bloch
  • Elwyn N Chomba
  • Albert Manasyan
  • Omrana Pasha
  • Linda L Wright
  • Fabian Esamai
  • Archana Patel
  • Janet Moore
  • Richard J Derman
  • Marion Koso-Thomas
  • Fernando Althabe
  • Ana Garces
  • Robert L Goldenberg
  • Pierre Buekens
  • Theodore C Belsches
  • Sarah Saleem
  • Alicia E Leadford
  • Bhala Kodkany
  • Alan H Jobe
  • Patricia Hibberd
  • Edward A Liechty
  • Jose M Belizan
  • Teelkien R Van Veen
  • Manimaran Ramani
  • Ariel A Salas
  • Jose Belizan
  • Robert Schelonka
  • Namasivayam Ambalavanan
  • Jamie B Warren
  • Rohan H Kambeyanda
  • Alyssa E Tilly
  • Tonya R Miller
  • Edward K Liechty
  • Patricia L Hibberd
  • Alicia Leadford
  • Dennis D Wallace
  • Suzanne Stalls
  • Hillary Mabeya
  • Shalece Kofford
  • Michael A Belfort
  • Neelofar Sami
  • Bhala S Kodkany
  • Sara Krzywanski

Detail Information

Publications29

  1. pmc Developmental trajectories of children with birth asphyxia through 36 months of age in low/low-middle income countries
    Jan L Wallander
    University of California, Merced, Merced, CA, United States Electronic address
    Early Hum Dev 90:343-8. 2014
    ..Resuscitation following birth asphyxia reduces mortality, but may be argued to increase risk for neurodevelopmental disability in survivors...
  2. doi Neonatal death in low- to middle-income countries: a global network study
    Jose M Belizan
    Institute for Clinical Effectiveness, Buenos Aires, Argentina
    Am J Perinatol 29:649-56. 2012
    ..To determine population-based neonatal mortality rates in low- and middle-income countries and to examine gestational age, birth weight, and timing of death to assess the potentially preventable neonatal deaths...
  3. pmc The Maternal and Newborn Health Registry Study of the Global Network for Women's and Children's Health Research
    Shivaprasad S Goudar
    Department of Medical Education, Jawaharlal Nehru Medical College, Belgaum, India
    Int J Gynaecol Obstet 118:190-3. 2012
    ..To implement a vital statistics registry system to register pregnant women and document birth outcomes in the Global Network for Women's and Children's Health Research sites in Asia, Africa, and Latin America...
  4. pmc Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings
    Nancy F Krebs
    Department of Pediatrics, Section of Nutrition, University of Colorado Denver, Aurora, CO 80045, USA
    Am J Clin Nutr 96:840-7. 2012
    ..Improved complementary feeding is cited as a critical factor for reducing stunting. Consumption of meats has been advocated, but its efficacy in low-resource settings has not been tested...
  5. pmc Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries
    Waldemar A Carlo
    University of Alabama at Birmingham, Birmingham, AL Center for Infectious Disease Research in Zambia, Lusaka, Zambia
    J Pediatr 162:705-712.e3. 2013
    ..To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children...
  6. pmc Assessment of obstetric and neonatal health services in developing country health facilities
    Albert Manasyan
    Centre for Infectious Disease Zambia, Lusaka, Zambia
    Am J Perinatol 30:787-94. 2013
    ....
  7. pmc Plastic bags for prevention of hypothermia in preterm and low birth weight infants
    Alicia E Leadford
    University of Alabama at Birmingham, Birmingham, AL 35249 7335, USA
    Pediatrics 132:e128-34. 2013
    ..This technique has not been studied in larger infants or in many resource-limited settings. The objective was to determine if placing preterm and low birth weight infants inside a plastic bag at birth maintains normothermia...
  8. pmc Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting
    Theodore C Belsches
    Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA
    Pediatrics 132:e656-61. 2013
    ..Our objective was to test the hypothesis that placement of term neonates in plastic bags at birth reduces hypothermia at 1 hour after birth in a resource-poor hospital...
  9. pmc A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial
    Omrana Pasha
    Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan
    BMC Med 11:215. 2013
    ..Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care...
  10. pmc First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings
    Elizabeth M McClure
    Department of Statistics and Epidemiology, RTI International, Durham, NC, USA
    BMC Pregnancy Childbirth 14:73. 2014
    ..Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown...
  11. pmc Causes of community stillbirths and early neonatal deaths in low-income countries using verbal autopsy: an International, Multicenter Study
    C Engmann
    Division of Neonatal Perinatal Medicine, Department of Pediatric and Maternal Child Health, University of North Carolina Schools of Medicine and Public Health, Chapel Hill, NC 27599 7596, USA
    J Perinatol 32:585-92. 2012
    ..We used verbal autopsy (VA), to understand causes of non-hospital, community-based SB and END from four low-income countries...
  12. pmc Birth attendants as perinatal verbal autopsy respondents in low- and middle-income countries: a viable alternative?
    C Engmann
    Department of Pediatrics and Maternal and Child Health, University of North Carolina Schools of Medicine and Public Health, UNC Hospitals, UNC Chapel Hill, Chapel Hill, NC 27599 7596, USA
    Bull World Health Organ 90:200-8. 2012
    ..To assess the feasibility of using birth attendants instead of bereaved mothers as perinatal verbal autopsy respondents...
  13. ncbi Maternal heart rate patterns in the first and second stages of labor
    Teelkien R Van Veen
    University Medical Center Groningen, Department of Obstetrics and Gynecology, Groningen, The Netherlands
    Acta Obstet Gynecol Scand 91:598-604. 2012
    ..Because second stage MHR accelerations generally show greater amplitude than FHR accelerations, tracings with repetitive accelerations during contractions (especially when Δ >20bpm) should be considered MHR until proven otherwise...
  14. pmc Neurodevelopmental outcomes in infants requiring resuscitation in developing countries
    Waldemar A Carlo
    University of Alabama, Birmingham, AL, USA
    J Pediatr 160:781-5.e1. 2012
    ..To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment...
  15. pmc Evaluation of meat as a first complementary food for breastfed infants: impact on iron intake
    K Michael Hambidge
    The University of Colorado Denver, Aurora, Colorado 80045, USA
    Nutr Rev 69:S57-63. 2011
    ..These trials are presently in progress in poor communities in Guatemala, Pakistan, Zambia, Democratic Republic of the Congo, and China...
  16. pmc Epidemiology of stillbirth in low-middle income countries: a Global Network Study
    Elizabeth M McClure
    Research Triangle Institute, Durham, NC, USA
    Acta Obstet Gynecol Scand 90:1379-85. 2011
    ..To determine population-based stillbirth rates and to determine whether the timing and maturity of the stillbirths suggest a high proportion of potentially preventable deaths...
  17. pmc Educational impact of the neonatal resuscitation program in low-risk delivery centers in a developing country
    Waldemar A Carlo
    University of Alabama at Birmingham, Birmingham, AL 35233 7335, USA
    J Pediatr 154:504-508.e5. 2009
    ..To evaluate the effectiveness of the American Academy of Pediatrics Neonatal Resuscitation Program (NRP) in improving knowledge, skills, and self-efficacy of nurse midwives in low-risk delivery clinics in a developing country...
  18. pmc Tobacco use and secondhand smoke exposure during pregnancy in two African countries: Zambia and the Democratic Republic of the Congo
    Elwyn Chomba
    University of Zambia, Lusaka, Zambia
    Acta Obstet Gynecol Scand 89:531-9. 2010
    ..To study pregnant women's knowledge, attitudes and behaviors towards tobacco use and secondhand smoke (SHS) exposure, and exposure to advertising for and against tobacco products in Zambia and the Democratic Republic of the Congo (DRC)...
  19. pmc Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT)
    Jan L Wallander
    Psychological Sciences and Health Sciences Research Institute, University of California, Merced, 5200 Lake Road, Merced, CA 95343, USA
    BMC Pediatr 10:27. 2010
    ....
  20. pmc High mortality rates for very low birth weight infants in developing countries despite training
    Waldemar A Carlo
    University of Alabama at Birmingham, School of Medicine, Department of Pediatrics, 176F Suite 9380, 619 S 19th St, Birmingham, AL 35249 7335, USA
    Pediatrics 126:e1072-80. 2010
    ..The study was designed to test the hypothesis that these training programs would reduce neonatal mortality rates for VLBW infants...
  21. pmc Complementary feeding: a Global Network cluster randomized controlled trial
    Nancy F Krebs
    University of Colorado Denver, Aurora, CO, USA
    BMC Pediatr 11:4. 2011
    ..Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated...
  22. pmc Cost-effectiveness of essential newborn care training in urban first-level facilities
    Albert Manasyan
    University of Alabama at Birmingham, 9380 Women and Infants Center, 1700 6th Avenue South, Birmingham, AL 35233, USA
    Pediatrics 127:e1176-81. 2011
    ..To determine the cost-effectiveness of the World Health Organization (WHO) Essential Newborn Care (ENC) training of health care providers in first-level facilities in the 2 largest cities in Zambia...
  23. doi ENC training reduces perinatal mortality in Karnataka, India
    Shivaprasad S Goudar
    Jawaharlal Nehru Medical College, Belgaum, India
    J Matern Fetal Neonatal Med 25:568-74. 2012
    ..To evaluate the effect of World Health Organization Essential Newborn Care course and the American Academy of Pediatrics Neonatal Resuscitation Program training on perinatal mortality in rural India...
  24. 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...
  25. 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...
  26. 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...
  27. 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
    ....
  28. 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...
  29. 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...