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As human immunodeficiency virus (HIV)-infected women gain access to combination antiretroviral therapy throughout sub-Saharan Africa, a growing number of infants are being born HIV-exposed but uninfected. Data about neonatal mortality and the impact of premature delivery, in this population are limited. We describe the 28-day mortality outcomes in a cohort of HIV-exposed infants who had ultrasound-confirmed gestational age in rural Uganda. There were 13 deaths among 351 infants, including 9 deaths in the perinatal period. Premature delivery was a strong predictor of mortality. The prevention of HIV transmission to infants is now possible in rural low-resource settings but the frequency of neonatal death among HIV-exposed infants remains extremely high, calling for new comprehensive interventions to reduce mortality in this growing population. © The Author [2013]. Published by Oxford University Press. All rights reserved.
This study included infants born in a randomized clinical trial of HIV-infected pregnant women who were enrolled between 15 December 2009 and 25 November 2012 in the rural town of Tororo, Uganda ({“type”:”clinical-trial”,”attrs”:{“text”:”NCT00993031″,”term_id”:”NCT00993031″}}NCT00993031). Ethical approval for the study was obtained from the Uganda National Council of Science and Technology, the Research and Ethics Committee of the School of Medicine at Makerere University and the Committee on Human Research at the University of California, San Francisco. Informed written consent for participation was obtained from all study participants at enrollment. ART-naïve women between 12 and 28 weeks gestation were randomized to receive either lopinavir-ritonavir- or efavirenz-based ART. All women received insecticide-treated bed nets and daily trimethoprim-sulfamethoxazole for prevention of opportunistic infections, and a standard prenatal care package of a safe water vessel, multivitamins and condoms as per standard of care for HIV-infected pregnant women in Uganda. GA was established using LMP and sonographic biometry (biparietal diameter, head circumference, abdominal circumference, femur length). Estimated date of delivery was based on LMP if the biometry was concordant within 7, 14 and 21 days in the first, second and third trimester, respectively, and based on ultrasound if LMP and biometry were not concordant. Women were encouraged to deliver at Tororo General Hospital (TGH), the district referral hospital. Midwives conducted deliveries and oxygen was available for resuscitation. Infants were seen every 2 weeks in the study clinic. Infants received zidovudine (AZT) prophylaxis after delivery in accordance with Ugandan Ministry of Health Guidelines, which changed during the course of the study. Seventy-six infants received AZT for 7 days, while 275 infants received AZT for 6 weeks after delivery. All infants had HIV DNA polymerase chain reaction (PCR) (Roche Amplicor HIV-1 DNA, v. 1.5) testing at birth. Maternal medical and obstetrical history was collected at enrollment. Women were followed in the study clinic for all clinical care, including monthly routine visits. Delivery data were collected by study physicians who reviewed the medical record as recorded by the hospital staff. Infants were weighed on a calibrated scale within 12 h of delivery. Infants were followed every 2 weeks for the first month after delivery. This analysis included all neonatal deaths occurring within the first 28 days of life. Causes of neonatal deaths were determined by two pediatricians blinded to maternal study intervention arm and categorized according to criteria established by Lawn et al. [12]. The primary outcome was neonatal death, defined as the death of a live-born infant within 28 days of birth. Perinatal death, defined as the death of a live-born infant within 7 days of life was also examined. Low birth weight (LBW) was defined as <2500 g at birth. Prematurity, or preterm birth, was defined as any infant born before 37 weeks of gestation. Infants were included in this analysis if they were born alive, and had either died or reached 28 days of life at the time of analysis. No infants were lost to follow-up. Continuous (GA, duration of ART from enrollment to delivery, maternal age, CD4 count at enrollment), dichotomous (LBW, twin gestation, infant sex, location of delivery, treatment arm) and ordinal (gravidity, 1- and 5-min Apgar scores) variables were evaluated as predictors in univariate. Adjusted odds ratios were estimated using a multivariate logistic regression model that included all predictors significant in univariate analysis. Data analysis was conducted using Stata version 9 (StataCorp LP, TX, US).
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