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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HD043464-01
Application #
6576743
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (24))
Program Officer
Wright, Linda
Project Start
2003-09-26
Project End
2008-04-30
Budget Start
2003-09-26
Budget End
2004-04-30
Support Year
1
Fiscal Year
2003
Total Cost
$642,085
Indirect Cost
Name
University of Alabama Birmingham
Department
Pediatrics
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Pasha, O; McClure, E M; Saleem, S et al. (2018) A prospective cause of death classification system for maternal deaths in low and middle-income countries: results from the Global Network Maternal Newborn Health Registry. BJOG 125:1137-1143
McClure, E M; Garces, A; Saleem, S et al. (2018) Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG 125:131-138
Goldenberg, Robert L; Saleem, Sarah; Ali, Sumera et al. (2017) Maternal near miss in low-resource areas. Int J Gynaecol Obstet 138:347-355
Swanson, David; Lokangaka, Adrien; Bauserman, Melissa et al. (2017) Challenges of Implementing Antenatal Ultrasound Screening in a Rural Study Site: A Case Study From the Democratic Republic of the Congo. Glob Health Sci Pract 5:315-324
Harrison, Margo S; Pasha, Omrana; Saleem, Sarah et al. (2017) A prospective study of maternal, fetal and neonatal outcomes in the setting of cesarean section in low- and middle-income countries. Acta Obstet Gynecol Scand 96:410-420
Garces, Ana L; McClure, Elizabeth M; PĂ©rez, Wilton et al. (2017) The Global Network Neonatal Cause of Death algorithm for low-resource settings. Acta Paediatr 106:904-911
Chomba, Elwyn; Carlo, Wally A; Goudar, Shivaprasad S et al. (2017) Effects of Essential Newborn Care Training on Fresh Stillbirths and Early Neonatal Deaths by Maternal Education. Neonatology 111:61-67
McClure, Elizabeth M; Goldenberg, Robert L; Jobe, Alan H et al. (2016) Reducing neonatal mortality associated with preterm birth: gaps in knowledge of the impact of antenatal corticosteroids on preterm birth outcomes in low-middle income countries. Reprod Health 13:61
Garces, Ana; McClure, Elizabeth M; Figueroa, Lester et al. (2016) A multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth: a case study from the Guatemalan Western Highlands. Reprod Health 13:63
Berrueta, Mabel; Hemingway-Foday, Jennifer; Thorsten, Vanessa R et al. (2016) Use of antenatal corticosteroids at health facilities and communities in low-and-middle income countries. Reprod Health 13:66

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