This application provides evidence that the Principal and Senior Foreign Investigators have an established record of major accomplishments in the Global Network including the design, implementation, and publication of single site and common protocol studies and clinical trials. For the next 5 year cycle, a rigorously-designed multicenter cluster randomized controlled clinical trial of the innovative use of a low cost and simple heart rate detector to guide neonatal resuscitation in primary care settings in low-income countries using the standard American Academy of Pediatrics Helping Babies Breathe protocol is proposed to determine its effectiveness in reducing early (7-day) neonatal mortality. The heart rate detector will assist birth attendants to determine the heart rate. Five to 10 percent of newborn infants appear lifeless at birth without breathing or crying, and determination of the heart rate and other signs of life is difficult for the birth attendants. For infants born alive, a increasing heart rate is the best indicator of an effective resuscitation. Assessment of heart rate changes is difficult to periderm with the usual clinical assessments in the field, and thus many infants die soon after birth. Neonatal resuscitation skills can be guided by heart rate detection even if a feeble heart rate is detected. If effective, electronic heart rate detection may be a breakthrough for deliveries by low- and middle-skilled birth attendants. The proposed team of investigators has collaborated for over 10 years and will continue to work with the NICHD and other sites of the Global Network to design, implement, analyze, and report innovative randomized trials and observational studies that are likely to reduce mortality and morbidities of mothers and infants. The qualifications and unequivocal commitment of the investigators the Zambian staff, as well as the full endorsement of the Government of Zambia, University Teaching Hospital (Zambia), University of Zambia, and the University of Alabama at Birmingham will ensure superior performance if this site is granted participation in the Network. The long-term objective is to improve local health care systems with education, training, implementation, and sustainability of programs to decrease neonatal mortality with the goal of long-term reduction in mortality and morbidity of infants.

Public Health Relevance

This project addresses the continued high rate of early (7-day) neonatal mortality despite resuscitation training in low income countries and the critical barrier f difficulty in the detection of the heart rate during the first minutes after birth by low- and midde-skilled birth attendants. The heart rate detector can be used during resuscitation to indicate that resuscitation measures are improving heart rate.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD078437-02
Application #
8658453
Study Section
Special Emphasis Panel (ZHD1-DSR-M (54))
Program Officer
Koso-Thomas, Marion
Project Start
2013-05-03
Project End
2018-04-30
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
2
Fiscal Year
2014
Total Cost
$658,302
Indirect Cost
$72,866
Name
University of Alabama Birmingham
Department
Pediatrics
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294