Confounding Variable
- Submitted by: richelle
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- Category: Science
- Date Submitted: 12/12/2011 12:32 PM
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Mitochondrial dysfunction following perinatal exposure to nucleoside analogues
Abstract: We conducted a study to estimate the association of in utero NA exposure and potential confounders and MD in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025, a multisite US cohort of HIV-infected women and their infants. The study population included HIV-uninfected or indeterminate infants born on or before November 1, 2006. This date restriction was used to allow 6 months of follow-up to evaluate the persistence or resolution of possible signs of MD at the time data were frozen for review. P1025 visits were conducted during routine prenatal and pediatric visits. Infant visits were scheduled at birth, 2, and 6 weeks of age, and at 4, 6, 9, and 12 months of age. Data were primarily abstracted from medical records of routine clinical care, and were supplemented by certain focused assessments including infant physical and neurological examinations, and Bayley neuropsychological testing. To identify possible or established cases of early MD according to the Enquête Perinatale Française (EPF) screening definition, a retrospective review of clinical data recorded on protocol case report forms were performed by clinicians blinded to in utero exposures. Possible and established cases (N = 3) were significantly more likely to be born in earlier years (all born in 2003) than noncases (N = 979, born in 2002-2006), P = 0.02. Among infants with maternal HIV viral loads recorded, the log median maternal HIV viral load during the first trimester was significantly higher among cases [N = 2, 5.2 (IQR: 4.6, 5.7)] than noncases [N = 355, 3.2 (IQR ≤ 2.6, 4.1), P = 0.01]. The maternal HIV viral load of the established case was 187 copies/mL at the time of the maternal HIV diagnosis early in the second trimester]. No significant difference in the distribution of other potential confounders was detected. Overall, peak maternal HIV viral loads in the first...
Abstract: We conducted a study to estimate the association of in utero NA exposure and potential confounders and MD in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025, a multisite US cohort of HIV-infected women and their infants. The study population included HIV-uninfected or indeterminate infants born on or before November 1, 2006. This date restriction was used to allow 6 months of follow-up to evaluate the persistence or resolution of possible signs of MD at the time data were frozen for review. P1025 visits were conducted during routine prenatal and pediatric visits. Infant visits were scheduled at birth, 2, and 6 weeks of age, and at 4, 6, 9, and 12 months of age. Data were primarily abstracted from medical records of routine clinical care, and were supplemented by certain focused assessments including infant physical and neurological examinations, and Bayley neuropsychological testing. To identify possible or established cases of early MD according to the Enquête Perinatale Française (EPF) screening definition, a retrospective review of clinical data recorded on protocol case report forms were performed by clinicians blinded to in utero exposures. Possible and established cases (N = 3) were significantly more likely to be born in earlier years (all born in 2003) than noncases (N = 979, born in 2002-2006), P = 0.02. Among infants with maternal HIV viral loads recorded, the log median maternal HIV viral load during the first trimester was significantly higher among cases [N = 2, 5.2 (IQR: 4.6, 5.7)] than noncases [N = 355, 3.2 (IQR ≤ 2.6, 4.1), P = 0.01]. The maternal HIV viral load of the established case was 187 copies/mL at the time of the maternal HIV diagnosis early in the second trimester]. No significant difference in the distribution of other potential confounders was detected. Overall, peak maternal HIV viral loads in the first...