Yvonne S Sininger1,2, Carmen G Condon3, Howard J Hoffman4, Amy J Elliott5,6, Hein J Odendaal7, Larry L Burd8,9,10, Michael M Myers2,11,12, William P Fifer2,11,12. 1. Department of Head & Neck Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA. 2. C&Y Consultants, LLC, Santa Fe, NM. 3. Division of Developmental Neuroscience, New York State Psychiatric Institute, New York, NY. 4. Epidemiology and Statistics Program, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), Bethesda, MD. 5. Center for Health Outcomes and Population Research, Sanford Research, Sioux Falls, SD. 6. Department of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls, SD. 7. Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Science, Stellenbosch University, Cape Town, South Africa. 8. Department of Pediatrics, University of North Dakota Fetal Alcohol Syndrome Center, Grand Forks, ND. 9. University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND. 10. University of North Dakota School of Medicine, Grand Forks, ND. 11. Department of Psychiatry, Columbia University Medical Center, New York, NY. 12. Department of Pediatrics, Columbia University Medical Center, New York, NY.
Abstract
BACKGROUND: The Prenatal Alcohol and Sudden Infant Death Syndrome and Stillbirth Network, known as the "Safe Passage Study," enrolled approximately 12,000 pregnant women from the United States and South Africa and followed the development of their babies through pregnancy and the infant's first year of life to investigate the role of prenatal alcohol exposure in the risk for sudden infant death syndrome (SIDS) and adverse pregnancy outcomes, such as stillbirth and fetal alcohol spectrum disorders. PURPOSE: Auditory system tests were included in the physiologic test battery used to study the effects of prenatal alcohol exposure on neurophysiology and neurodevelopment, as well as potential causal relationships between neurodevelopmental disorders and SIDS and/or stillbirth. The purpose of this manuscript is to describe normative results when using the auditory test battery applied. RESEARCH DESIGN: The test battery included the auditory brainstem response (ABR) and transient-evoked otoacoustic emissions (TEOAEs). Data were collected on individual ears of newborns and 1-month-old infants. STUDY SAMPLE: From a cohort of 6,070 with auditory system exams, a normative subsample of 325 infants were selected who were not exposed prenatally to alcohol, cigarette smoke, or drugs nor were they preterm or low birthweight. The subsample is small relative to the overall study because of strict criteria for no exposure to substances known to be associated with SIDS or stillbirth and the exclusion of preterm and low birthweight infants. Expectant mothers were recruited from general maternity at two comprehensive clinical sites, in the northern plains in the United States and in Cape Town, South Africa. These populations were selected for study because both were known to be at high-risk for SIDS and stillbirth. DATA COLLECTION AND ANALYSIS: ABR and TEOAE recordings were stored electronically. Peak latency and amplitude analysis of ABRs were determined by study personnel, and results were evaluated for differences by age, sex, test site, race, and ear (left versus right). RESULTS: TEOAE findings were consistent with existing literature including the increase in signal-to-noise (SNR) over the first month of life. The SNR increase is due to an increase in amplitude of the emission. TEOAE amplitude asymmetry favoring the right ear was found, whereas SNR asymmetry was not, perhaps because of the small sample size. A nonsignificant trend toward larger responses in female babies was found; a result that is generally statistically significant in studies with larger samples. Latencies were found to be shorter in ABRs elicited in the right ear with amplitudes that were slightly bigger on average. An expected decrease in wave V latency was observed from birth to 1-month of age, but the finding was of borderline significance (p = 0.058). CONCLUSIONS: One month is a short time to judge development of the auditory system; however, the ABR and TEOAE findings were consistent with current literature. We conclude that the auditory system data acquired for the Safe Passage Study, as reflected in the data obtained from this cohort of "unexposed" infants, is consistent with published reports of these auditory system measures in the general population. American Academy of Audiology.
BACKGROUND: The Prenatal Alcohol and Sudden Infant Death Syndrome and Stillbirth Network, known as the "Safe Passage Study," enrolled approximately 12,000 pregnant women from the United States and South Africa and followed the development of their babies through pregnancy and the infant's first year of life to investigate the role of prenatal alcohol exposure in the risk for sudden infant death syndrome (SIDS) and adverse pregnancy outcomes, such as stillbirth and fetal alcohol spectrum disorders. PURPOSE: Auditory system tests were included in the physiologic test battery used to study the effects of prenatal alcohol exposure on neurophysiology and neurodevelopment, as well as potential causal relationships between neurodevelopmental disorders and SIDS and/or stillbirth. The purpose of this manuscript is to describe normative results when using the auditory test battery applied. RESEARCH DESIGN: The test battery included the auditory brainstem response (ABR) and transient-evoked otoacoustic emissions (TEOAEs). Data were collected on individual ears of newborns and 1-month-old infants. STUDY SAMPLE: From a cohort of 6,070 with auditory system exams, a normative subsample of 325 infants were selected who were not exposed prenatally to alcohol, cigarette smoke, or drugs nor were they preterm or low birthweight. The subsample is small relative to the overall study because of strict criteria for no exposure to substances known to be associated with SIDS or stillbirth and the exclusion of preterm and low birthweight infants. Expectant mothers were recruited from general maternity at two comprehensive clinical sites, in the northern plains in the United States and in Cape Town, South Africa. These populations were selected for study because both were known to be at high-risk for SIDS and stillbirth. DATA COLLECTION AND ANALYSIS: ABR and TEOAE recordings were stored electronically. Peak latency and amplitude analysis of ABRs were determined by study personnel, and results were evaluated for differences by age, sex, test site, race, and ear (left versus right). RESULTS: TEOAE findings were consistent with existing literature including the increase in signal-to-noise (SNR) over the first month of life. The SNR increase is due to an increase in amplitude of the emission. TEOAE amplitude asymmetry favoring the right ear was found, whereas SNR asymmetry was not, perhaps because of the small sample size. A nonsignificant trend toward larger responses in female babies was found; a result that is generally statistically significant in studies with larger samples. Latencies were found to be shorter in ABRs elicited in the right ear with amplitudes that were slightly bigger on average. An expected decrease in wave V latency was observed from birth to 1-month of age, but the finding was of borderline significance (p = 0.058). CONCLUSIONS: One month is a short time to judge development of the auditory system; however, the ABR and TEOAE findings were consistent with current literature. We conclude that the auditory system data acquired for the Safe Passage Study, as reflected in the data obtained from this cohort of "unexposed" infants, is consistent with published reports of these auditory system measures in the general population. American Academy of Audiology.
Authors: Peter S Blair; Daniel Rubens; Anna Pease; Diane Mellers; Jenny Ingram; Andrew K Ewer; Marta C Cohen; Peter Sidebotham; Martin Ward Platt; Robert Coombs; Adrian Davis; Amanda Hall; Peter Fleming Journal: BMJ Open Date: 2019-07-18 Impact factor: 2.692