Study Image Clustered Trial for Improving Perinatal Care in Uruguay/Argentina: A cluster randomized controlled trial of a behavioral intervention in Argentina and Uruguay that will increase the use of two evidence-based birth practices (EBP), the selective use of episiotomies and active management of the third stage of labor.
Primary Manuscript
Althabe FA, Buekens P, Bergel E, Belizán JM, Campbell MK, Moss N, Hartwell T, Wright LL. A behavioral intervention to improve obstetrical care. New Engl J Med. 2008 May 1;358(18):1929-40. PMID 18450604
Participating Institutions
Tulane School of Public Health and Tropical Medicine Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
RTI International

Study Image Neonatal Resuscitation in Zambia: To test training staff in the Neonatal Resuscitation Program and the WHO integrated Management of Pregnancy and Childbirth: Pregnancy, Childbirth, Postpartum and Newborn Care Guide for Essential Practice (2003): Essential Newborn Care Program (ENC) compared to training staff in the ENC alone will reduce neonatal mortality or stillbirth (7 days).
Primary Manuscript
Newborn care training of midwives and neonatal and perinatal mortality rates in a developing country. Carlo WA, McClure EM, Chomba E, Chakraborty H, Hartwell T, Harris H, Lincetto O, Wright LL. Pediatrics. 2010 Nov;126(5):e1064-71. doi: 10.1542/peds.2009-3464.
Participating Institutions
University of Alabama at Birmingham University Teaching Hospital, Lusaka
RTI International

Study Image Systematic Pediatric Care for Oral Clefts: Study of an intensive pediatric care intervention designed to reduce neonatal mortality of children born with oral clefts and to follow a subset of these who have been randomized into normal or more intensive pediatric care through two years.
Primary Manuscript
Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, Kindem M, Chakraborty H, Dutra G, López-Camelo JS, Orioli IM, Murray JC. The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts. BMC Pediatr. 2011 Dec 28;11:121.
Participating Institutions
University of Iowa Estudio Colaborativo Latino Americano de Malformaciones Congenitas (ECLAMC)
RTI International

Study Image Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala: A randomized controlled trial comparing zinc supplementation to complementary feeding in infants between 6-12 months of age.
Primary Manuscript
Krebs NF, Mazariegos M, Tshefu A, Bose C, Sami N, Chomba E, Carlo W, Goco N, Kindem M, Wright LL, Hambidge KM; Complementary Feeding Study Group. Meat consumption is associated with less stunting among toddlers in four diverse low-income settings. Food Nutr Bull. 2011 Sep;32(3):185-91. PMCID:PMC3918945 PMID 22073791
Participating Institutions
University of Colorado Center for Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)
RTI International

Study Image Prevention of Infection in Indian Neonates: A study of the colonization ability of a probiotic supplement (Lactobacillus plantarum) in the infant gut.
Primary Manuscript
Panigrahi P, Parida S, Pradhan L, Mohapatra SS, Misra PR, Johnson JA, Chaudhry R, Taylor S, Hansen NI, Gewolb IH. Long-term colonization of a Lactobacillus plantarum synbiotic preparation in the neonatal gut. J Pediatr Gastroenterol Nutr. 2008 Jul;47(1):45-53. PMID 18607268
Participating Institutions
University of Maryland School of Medicine SCB Medical College, Orissa
RTI International

Study Image A Randomized trial of chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: A randomized controlled trial to determine the efficacy of a vaginal/neonatal wash to reduce 28-day neonatal and maternal morbidity and mortality.
Primary Manuscript
Saleem S, Rouse DJ, McClure EM, Reza T, Yahya Y, Memon IA, Khan NH, Memon G, Soomro N, Pasha O, Wright L, Moore J, Goldenberg RL. A Randomized trial of chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity. Am J Ob Gyn. 2010 Jun;115(6):1225-32. PMCID:PMC3893917 PMID 20502294
Participating Institutions
University of Alabama at Birmingham Aga Khan University, Karachi
RTI International

Study Image First Breath: Almost 4,000 birth attendants from 100 GN communities with more than 150,000 deliveries were trained in neonatal care and resuscitation, using the WHO Essential Newborn Care training program, followed by randomization to the Neonatal Resuscitation Program. The trial significantly reduced perinatal deaths. As many as 30 to 40% of perinatal deaths may be averted with this simple intervention which led to the development of Helping Babies Breathe.
Primary Manuscript
Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Krebs NF, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Wright LL. Newborn care training and perinatal mortality in developing countries. N Engl J Med. 2010 Feb 18;362(7):614-23. PMCID: PMC3565382 PMID 20164485
Participating Institutions
Tulane School of Public Health and Tropical Medicine JN Medical College, Belgaum, India
Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina University of Alabama at Birmingham
Aga Khan University, Karachi, Pakistan University Teaching Hospital, Lusaka, Zambia
Massachusetts General Hospital University of Colorado Denver
Lata Medical Research Foundation, Nagpur, India Instituto de Nutrición de Centro América y Panamá
Kinshasa School of Public Health, Democratic Republic of Congo Christiana Care
Moi University, Eldoret, Kenya RTI International

Study Image Complementary Feeding (FIRST BITES): The primary outcome measure was linear growth velocity; secondary outcomes were neurocognitive development, infectious disease morbidity, dietary diversity, and micronutrient status. The trial was conducted in 4 of the 7 Global Network sites (Guatemala, Pakistan, Zambia, and the Democratic Republic of the Congo). The trial began in July 2008; the primary paper demonstrated that the linear growth velocity of infants that received multiply enriched cereal was similar to those that received meat as a complementary feeding.
Primary Manuscript
Krebs NF, Hambidge M, Mazariegos M, Westcott J, Goco N, Wright LL, Koso-Thomas M, Tshefu A, Bose C, Pasha O, Goldenberg RL, Chomba E, Carlo WA, Kindem M, Das A, Hartwell TD, McClure EM. Complementary feeding: A Global Network cluster randomized controlled trial. BMC Pediatr. 2011 Jan 13;11(1):4. PMCID: PMC3032692 PMID 21232139
Participating Institutions
University of North Carolina at Chapel Hill School of Medicine University Teaching Hospital, Lusaka, Zambia
Kinshasa School of Public Health, Democratic Republic of Congo University of Colorado Denver
University of Alabama at Birmingham Instituto de Nutrición de Centro América y Panamá
Aga Khan University, Karachi, Pakistan RTI International

Study Image BRAIN: The BRAIN study is a recently completed randomized trial to evaluate the impact of a home-based, parent-provided early intervention on the neurodevelopmental outcome of infants who were resuscitated for mild to moderate asphyxia in the FIRST BREATH trial in Zambia, Pakistan, and Belgaum, India. All infants received case management and growth monitoring. Trained, certified staff masked to the infants' history conducted the neurodevelopmental testing, which was adapted for use in the relevant cultural context. The early developmental intervention started soon after birth and continued until three years of age. Survivors of mild or moderate birth asphyxia had neurodevelopmental outcomes in the normal range: their MDI and PDI scores improved by an average of 5 points in the early intervention group compared to the case management control group. The trial demonstrated that home-based, parent provided early intervention in children resuscitated at birth improved cognitive and psychomotor outcomes. Neurodevelopmental outcomes among asphyxiated infants were similar to those of non-asphyxiated infants and documented that the intervention benefitted children at low-risk for neurodevelopmental difficulties: (J Pediatr, in press). Neurodevelopmental assessment expertise developed for this trial may provide a resource for ICs and NGOs who are working in interventions to improve neurodevelopmental outcome in the participating countries.
Primary Manuscript
Carlo WA, Goudar SS, Pasha O, Chomba E, Wallander JL, Biasini FJ, McClure EM, Thorsten V, Chakraborty H, Shearer DL, Wright LL, and the BRAIN-HIT Committee and the NICHD Global Network for Women's and Children's Health Research Investigators. Randomized trial of early developmental intervention in children after birth asphyxia in developing countries.: J Pediatr. 2013 Apr;162(4):705-712.e3. doi: 10.1016/j.jpeds.2012.09.052. Epub 2012 Nov 16. PMCID:PMC3582821 PMID:23164311
Participating Institutions
University of Alabama at Birmingham JN Medical College, Belgaum, India
University Teaching Hospital, Lusaka, Zambia Aga Khan University, Karachi, Pakistan
Christiana Care RTI International

HBB
Helping Babies Breathe (HBB) The HBB initiative represents a further development of the Global Network FIRST BREATH trial, which was designed to provide skilled birth attendants to babies wherever they are born. HBB is being rolled out globally by the Global Network, the American Academy of Pediatrics, USAID and its partners, Saving Newborn Lives, Laerdal, Inc. It was field tested in 5 sites, 2 of which were Global Network sites in Kenya and Belgaum, India, and includes the development of a new low-cost neonatal simulator and resuscitation bag. USAID requested that the Global Network evaluate the impact of Helping Babies Breathe on neonatal survival which is underway in 3 Global Network sites in Kenya, and Nagpur and Belgaum, India. USAID will conduct the programmatic evaluation for 4 sites. The GN HBB pre-post study has an important public health goal: to demonstrate whether HBB training of birth attendants (BAs) in 71 participating facilities that deliver many pregnant women living in GN communities will improve the outcome of all neonates delivered in the GN clusters in a 1-yr pre-post study. Teams of HBB Master Trainers (MDs and RNs), paired with core master trainers from Nagpur, Belgaum, and Kenya trained a large cohort of site Master Trainers in May, 2012, in order to scale up HBB expertise in 4 months. Subsequently 1,636 birth attendants have been trained in HBB at the 71 participating facilities and strong QI program implemented in the facilities.
Primary Manuscript
Pending
Participating Institutions
Christiana Care JN Medical College, Belgaum, India
Massachusetts General Hospital Moi University, Eldoret, Kenya
RTI International
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