Browsing by Author "McClure EM"

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A color-coded tape for uterine height measurement: a tool to identify preterm pregnancies in low resource settings.
(2015) Althabe F; Berrueta M; Hemingway-Foday J; Mazzoni A; Bonorino CA; Gowdak A; Gibbons L; Bellad MB; Metgud MC; Goudar S; Kodkany BS; Derman RJ; Saleem S; Iqbal S; Ala SH; Goldenberg RL; Chomba E; Manasyan A; Chiwila M; Imenda E; Mbewe F; Tshefu A; Lokomba V; Bose CL; Moore J; Meleth S; McClure EM; Koso-Thomas M; Buekens P; Belizán JM; Department of Community Health Sciences, Aga Khan University, Karachi Pakistan.; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.; Eunice Kennedy Shriver NICHD, Bethesda, Maryland, United States of America.; Department of Obstetrics and Gynecology, Columbia University, New York, New York, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of North Carolina, Chapel Hill, North Carolina, United States of America.; University of North Carolina, Chapel Hill, North Carolina, United States of America.; RTI International; Durham, North Carolina, United States of America.; Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.; School of Public Health and Tropical Medicine, Tulane University, Louisiana, United States of America.; KLE University's Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.; Department of Obstetrics, Sindh Government Qatar Hospital, Karachi Pakistan.; Christiana Care, Newark, Delaware, United States of America.; University Teaching Hospital, Lusaka, Zambia.; Department of Obstetrics, Sobhraj Maternity Hospital, Karachi, Pakistan.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
INTRODUCTION: Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies. METHODS: We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20-23.6 weeks, 24.0-35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pakistan and Zambia. Providers masked to the ultrasound GA measured UH. Receiver operating characteristics (ROC) analysis was conducted. RESULTS: 1,029 pregnant women were enrolled. In all countries the tapes were most effective identifying pregnancies between 20.0-35.6 weeks, compared to the other GAs. The ROC areas under the curves and 95% confidence intervals were: Argentina 0.69 (0.63, 0.74); Zambia 0.72 (0.66, 0.78), India 0.84 (0.80, 0.89), and Pakistan 0.83 (0.78, 0.87). The sensitivity and specificity (and 95% confidence intervals) for identifying pregnancies between 20.0-35.6 weeks, respectively, were: Argentina 87% (82%-92%) and 51% (42%-61%); Zambia 91% (86%-95%) and 50% (40%-60%); India 78% (71%-85%) and 89% (83%-94%); Pakistan 63% (55%-70%) and 94% (89%-99%). CONCLUSIONS: We observed moderate-good accuracy identifying pregnancies ≤ 35.6 weeks gestation, with potential usefulness at the community level in low-middle income countries to facilitate the preterm identification and interventions to reduce preterm neonatal mortality. Further research is needed to validate these findings on a population basis.
Association between birth attendant type and delivery site and perinatal outcomes.
(2019-May) Manasyan A; Chomba E; Moore J; Wallace D; McClure EM; Koso-Thomas M; Carlo WA; RTI International, Durham, NC, USA.; University of Alabama at Birmingham, Birmingham, AL, USA.; University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD, USA.
OBJECTIVE: To test the hypothesis that modified perinatal mortality, early neonatal mortality, and other measures of perinatal mortality are lower with facility births than with home births among deliveries conducted by traditional birth attendants (TBAs) or nurse-midwives. METHOD: This population-based observational study used data collected prospectively for home and facility deliveries conducted by TBAs and nurse-midwives in 13 rural communities in Zambia between September 1, 2009, and December 31, 2015. RESULTS: We enrolled 48 956 pregnant women. In adjusted analysis, modified perinatal mortality (adjusted odds ratio [aOR] 0.63, 95% confidence interval [CI] 0.45-0.88), early neonatal mortality (0.48, 0.33-0.69), and fresh stillbirth/day-1 neonatal mortality (0.55, 0.38-0.80) were lower among home deliveries than among facility deliveries conducted by TBAs, but did not differ among deliveries conducted by nurse-midwives. Rates of fresh stillbirth did not differ between home and facility delivery by either TBAs (aOR 1.03, 95% CI 0.64-1.66) or nurse-midwives (1.19, 0.67-2.10). CONCLUSION: Our findings show significant reductions in modified perinatal mortality, early neonatal mortality, and fresh stillbirth/day-1 neonatal mortality among home deliveries done by TBAs. This may be explained by robust community structures built by our program and referral bias of complicated cases.
Developmental trajectories of children with birth asphyxia through 36 months of age in low/low-middle income countries.
(2014-Jul) Wallander JL; Bann C; Chomba E; Goudar SS; Pasha O; Biasini FJ; McClure EM; Thorsten V; Wallace D; Carlo WA; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, AL, United States.; KLE University's Jawaharlal Nehru Medical College, Belgaum, India.; Research Triangle Institute International, Durham, NC, United States.; University of Alabama at Birmingham, Birmingham, AL, United States.; University of California, Merced, Merced, CA, United States. Electronic address: Jwallander@ucmerced.edu.; Aga Kahn University Medical College, Karachi, Pakistan.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Resuscitation following birth asphyxia reduces mortality, but may be argued to increase risk for neurodevelopmental disability in survivors. AIMS: To test the hypothesis that development of infants who received resuscitation following birth asphyxia is not significantly different through 36months of age from infants who had healthy births. STUDY DESIGN: Prospective observational cohort design comparing infants exposed to birth asphyxia with resuscitation or healthy birth. SUBJECTS: A random sample of infants with birth asphyxia who received bag-and-mask resuscitation was selected from birth records in selected communities in 3 countries. EXCLUSION CRITERIA: birth weight<1500g, severely abnormal neurological examination at 7days, mother<15years, unable to participate, or not expected to remain in the target area. A random sample of healthy-birth infants (no resuscitation, normal neurological exam) was also selected. Eligible=438, consented=407, and ≥1 valid developmental assessment during the first 36months=376. OUTCOME MEASURE(S): Bayley Scales of Infant Development-II Mental (MDI) and Psychomotor (PDI) Development Index. RESULTS: Trajectories of MDI (p=.069) and PDI (p=.143) over 3 yearly assessments did not differ between children with birth asphyxia and healthy-birth children. Rather there was a trend for birth asphyxia children to improve more than healthy-birth children. CONCLUSIONS: The large majority of infants who are treated with resuscitation and survived birth asphyxia can be expected to evidence normal development at least until age 3. The risk for neurodevelopmental disability should not justify the restriction of effective therapies for birth asphyxia.
Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries.
(2023-May-23) Manasyan A; Salas AA; Nolen T; Chomba E; Mazariegos M; Tshefu Kitoto A; Saleem S; Naqvi F; Hambidge KM; Goco N; McClure EM; Wallander JL; Biasini FJ; Goldenberg RL; Bose CL; Koso-Thomas M; Krebs NF; Carlo WA; University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, USA.; Aga Khan University, Karachi, Pakistan.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.; Research Triangle Institute, Durham, North Carolina, USA.; The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Department of Pediatrics, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.; Department of Pediatrics, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA AlbertManasyan@uabmc.edu.; Department of Obstetrics and Gynecology, Columbia University, New York, New York, UK.; University of Kinshasa, Kinshasa, Congo (the Democratic Republic of the).; Psychological Sciences and Health Sciences Research Institute, University of California Merced, Merced, California, USA.; University of Colorado Denver, Denver, Colorado, USA.; University of Zambia, Lusaka, Zambia.; Department of Reproductive, Maternal, Newborn, and Child Health, Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Institute of Nutrition for Central America and Panamá (INCAP), Guatemala City, Panama.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
OBJECTIVE: The Bayley Scales of Infant Development (BSID) is the most used diagnostic tool to identify neurodevelopmental disorders in children under age 3 but is challenging to use in low-resource countries. The Ages and Stages Questionnaire (ASQ) is an easy-to-use, low-cost clinical tool completed by parents/caregivers that screens children for developmental delay. The objective was to determine the performance of ASQ as a screening tool for neurodevelopmental impairment when compared with BSID second edition (BSID-II) for the diagnosis of moderate-to-severe neurodevelopmental impairment among infants at 12 and 18 months of age in low-resource countries. METHODS: Study participants were recruited as part of the First Bites Complementary Feeding trial from the Democratic Republic of Congo, Zambia, Guatemala and Pakistan between October 2008 and January 2011. Study participants underwent neurodevelopmental assessment by trained personnel using the ASQ and BSID-II at 12 and 18 months of age. RESULTS: Data on both ASQ and BSID-II assessments of 1034 infants were analysed. Four of five ASQ domains had specificities greater than 90% for severe neurodevelopmental delay at 18 months of age. Sensitivities ranged from 23% to 62%. The correlations between ASQ communications subscale and BSID-II Mental Development Index (MDI) (r=0.38) and between ASQ gross motor subscale and BSID-II Psychomotor Development Index (PDI) (r=0.33) were the strongest correlations found. CONCLUSION: At 18 months, ASQ had high specificity but moderate-to-low sensitivity for BSID-II MDI and/or PDI <70. ASQ, when administered by trained healthcare workers, may be a useful screening tool to detect severe disability in infants from rural low-income to middle-income settings. TRIAL REGISTRATION NUMBER: NCT01084109.
Junk food use and neurodevelopmental and growth outcomes in infants in low-resource settings.
(2024) Chiwila MK; Krebs NF; Manasyan A; Chomba E; Mwenechanya M; Mazariegos M; Sami N; Pasha O; Tshefu A; Lokangaka A; Goldenberg RL; Bose CL; Koso-Thomas M; Goco N; Do BT; McClure EM; Hambidge KM; Westcott JE; Carlo WA; School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo.; University of Colorado School of Medicine, Aurora, CO, United States.; Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.; Department of Obstetrics and Gynecology, Columbia University, New York, NY, United States.; Department of Pediatrics, University of North Carolina, Chapel Hill, NC, United States.; Eunice Kennedy Shiver National Institute of Child Health and Human Development, Bethesda, MD, United States.; Global Network, University Teaching Hospital, Lusaka, Zambia.; Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.; Instituto de Nutrición de Centro América y Panamá, Guatemala City, Guatemala.; Research Triangle Institute International, Durham, NC, United States.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
INTRODUCTION: Feeding infants a sub-optimal diet deprives them of critical nutrients for their physical and cognitive development. The objective of this study is to describe the intake of foods of low nutritional value (junk foods) and identify the association with growth and developmental outcomes in infants up to 18 months in low-resource settings. METHODS: This is a secondary analysis of data from an iron-rich complementary foods (meat versus fortified cereal) randomized clinical trial on nutrition conducted in low-resource settings in four low- and middle-income countries (Democratic Republic of the Congo, Guatemala, Pakistan, and Zambia). Mothers in both study arms received nutritional messages on the importance of exclusive breastfeeding up to 6 months with continued breastfeeding up to at least 12 months. This study was designed to identify the socio-demographic predictors of feeding infants' complementary foods of low nutritional value (junk foods) and to assess the associations between prevalence of junk food use with neurodevelopment (assessed with the Bayley Scales of Infant Development II) and growth at 18 months. RESULTS: 1,231 infants were enrolled, and 1,062 (86%) completed the study. Junk food feeding was more common in Guatemala, Pakistan, and Zambia than in the Democratic Republic of Congo. 7% of the infants were fed junk foods at 6 months which increased to 70% at 12 months. Non-exclusive breastfeeding at 6 months, higher maternal body mass index, more years of maternal and paternal education, and higher socioeconomic status were associated with feeding junk food. Prevalence of junk foods use was not associated with adverse neurodevelopmental or growth outcomes. CONCLUSION: The frequency of consumption of junk food was high in these low-resource settings but was not associated with adverse neurodevelopment or growth over the study period.
Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries.
(2013-Apr) Carlo WA; Goudar SS; Pasha O; Chomba E; Wallander JL; Biasini FJ; McClure EM; Thorsten V; Chakraborty H; Wallace D; Shearer DL; Wright LL; University of Alabama at Birmingham, Birmingham, AL; Center for Infectious Disease Research in Zambia, Lusaka, Zambia. wcarlo@peds.uab.edu; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
OBJECTIVE: To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. STUDY DESIGN: This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. RESULTS: MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164). CONCLUSIONS: This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.
The Global Network Neonatal Cause of Death algorithm for low-resource settings.
(2017-Jun) Garces AL; McClure EM; Pérez W; Hambidge KM; Krebs NF; Figueroa L; Bose CL; Carlo WA; Tenge C; Esamai F; Goudar SS; Saleem S; Patel AB; Chiwila M; Chomba E; Tshefu A; Derman RJ; Hibberd PL; Bucher S; Liechty EA; Bauserman M; Moore JL; Koso-Thomas M; Miodovnik M; Goldenberg RL; RTI International, Durham, NC, USA.; University of Alabama at Birmingham, Birmingham, AL, USA.; Aga Khan University, Karachi, Pakistan.; Indiana University, Indianapolis, IN, USA.; Moi University School of Medicine, Eldoret, Kenya.; Columbia University Medical Center, New York, NY, USA.; Kinshasa School of Public Health, Kinshasa, DRC.; University of Colorado, Denver, CO, USA.; Lata Medical Research Foundation, Nagpur, India.; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; INCAP, Guatemala City, Guatemala.; CIDRZ, Lusaka, Zambia.; KLE University's JN Medical College, Belgaum, India.; Thomas Jefferson University, Philadelphia, PA, USA.; University of Zambia, Lusaka, Zambia.; NICHD, Bethesda, MD, USA.; Boston University, Boston, MA, USA.
AIM: This study estimated the causes of neonatal death using an algorithm for low-resource areas, where 98% of the world's neonatal deaths occur. METHODS: We enrolled women in India, Pakistan, Guatemala, the Democratic Republic of Congo, Kenya and Zambia from 2014 to 2016 and tracked their delivery and newborn outcomes for up to 28 days. Antenatal care and delivery symptoms were collected using a structured questionnaire, clinical observation and/or a physical examination. The Global Network Cause of Death algorithm was used to assign the cause of neonatal death, analysed by country and day of death. RESULTS: One-third (33.1%) of the 3068 neonatal deaths were due to suspected infection, 30.8% to prematurity, 21.2% to asphyxia, 9.5% to congenital anomalies and 5.4% did not have a cause of death assigned. Prematurity and asphyxia-related deaths were more common on the first day of life (46.7% and 52.9%, respectively), while most deaths due to infection occurred after the first day of life (86.9%). The distribution of causes was similar to global data reported by other major studies. CONCLUSION: The Global Network algorithm provided a reliable cause of neonatal death in low-resource settings and can be used to inform public health strategies to reduce mortality.