Browsing by Author "McGowan, Elisabeth C."
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Item Are Outcomes of Extremely Preterm Infants Improving? Impact of Bayley Assessment on Outcomes(Elsevier, 2012) Vohr, Betty R.; Stephens, Bonnie E.; Higgins, Rosemary D.; Bann, Carla M.; Hintz, Susan R.; Epi, M. S.; Das, Abhik; Newman, Jamie E.; Peralta-Carcelen, Myriam; Yolton, Kimberly; Dusick, Anna M.; Evans, Patricia W.; Goldstein, Ricki F.; Ehrenkranz, Richard A.; Pappas, Athina; Adams-Chapman, Ira; Wilson-Costello, Deanne E.; Bauer, Charles R.; Bodnar, Anna; Heyne, Roy J.; Vaucher, Yvonne E.; Dillard, Robert G.; Acarregui, Michael J.; McGowan, Elisabeth C.; Myers, Gary J.; Fuller, Janell; Eunice Kennedy Shriver National Institute of Child Health and Network Human Development Neonatal Research; Pediatrics, School of MedicineObjectives: To compare 18- to 22-month cognitive scores and neurodevelopmental impairment (NDI) in 2 time periods using the National Institute of Child Health and Human Development's Neonatal Research Network assessment of extremely low birth weight infants with the Bayley Scales of Infant Development, Second Edition (Bayley II) in 2006-2007 (period 1) and using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III), with separate cognitive and language scores, in 2008-2011 (period 2). Study design: Scores were compared with bivariate analysis, and regression analyses were run to identify differences in NDI rates. Results: Mean Bayley III cognitive scores were 11 points higher than mean Bayley II cognitive scores. The NDI rate was reduced by 70% (from 43% in period 1 to 13% in period 2; P < .0001). Multivariate analyses revealed that Bayley III contributed to a decreased risk of NDI by 5 definitions: cognitive score <70 and <85, cognitive or language score <70; cognitive or motor score <70, and cognitive, language, or motor score <70 (P < .001). Conclusion: Whether the Bayley III is overestimating cognitive performance or whether it is a more valid assessment of emerging cognitive skills than the Bayley II is uncertain. Because the Bayley III identifies significantly fewer children with disability, it is recommended that all extremely low birth weight infants be offered early intervention services at the time of discharge from the neonatal intensive care unit, and that Bayley scores be interpreted with caution.Item Association of High Screen-Time Use With School-age Cognitive, Executive Function, and Behavior Outcomes in Extremely Preterm Children(American Medical Association, 2021) Vohr, Betty R.; McGowan, Elisabeth C.; Bann, Carla; Das, Abhik; Higgins, Rosemary; Hintz, Susan; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of MedicineImportance: Both preterm birth and increased screen time are known to be associated with an increase in risk of developmental and behavioral sequelae. The association between high screen time or a television or computer in the bedroom in early school age and adverse cognitive, executive function, language, and behavior outcomes of extremely preterm children (EPT) is not well understood. Objective: To assess the association of high screen time with cognition, language, executive function, and behavior of EPT children aged 6 to 7 years; a second objective was to examine the association between high screen time and rates of structured physical activity and weight. Design, setting, and participants: This cohort study was a secondary analysis from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial Neuroimaging and Neurodevelopmental Outcomes school-aged cohort and includes 414 EPT children born between February 1, 2005, and February 28, 2009, and evaluated in between 2012 and 2016 at ages 6 years 4 months to 7 years 2 months. The study was conducted from July 7, 2012, and August 15, 2016, and data were analyzed between December 10, 2018, and April 1, 2021. Exposures: Cohorts included children exposed to low (≤2 hours per day) vs high (>2 hours per day) amounts of screen time and by the presence (no vs yes) of a television/computer in the bedroom. Main outcomes and measures: In addition to growth parameters, assessments included the Wechsler Intelligence Scale for Children-IV, the Behavior Rating Inventory of Executive Function, the Developmental Neuropsychological Assessment, the Conners 3rd Edition-Parent Short-Form, and the Social Communication Questionnaire. Results: Of the 414 children included in the analysis, 227 (55%) were boys; mean (SD) birth weight was 870.6 (191) g. A total of 238 children (57%) had high screen time and 266 (64%) had a television/computer in their bedroom. In multivariable linear regressions adjusted for center, male sex, gestational age, and social determinants of health, high screen time was independently associated with the following mean (SE) test score changes: lower full-scale IQ (-3.92 [1.64]; P = .02); an increase in association with deficits in executive functions, including metacognition (8.18 [3.01]; P = .007), global executive function (7.49 [2.99]; P = .01), inhibition (-0.79 [0.38]; P = .03), and Conners 3rd Edition-Parent Short-Form inattention (3.32 [1.67]; P = .047). A television/computer in the bedroom was associated with an increase in inhibition (-0.80 [0.39]; P = .04) and hyperactivity/impulsivity (3.50 [1.75]; P = .046) problems. Conclusions and relevance: The findings of this study suggest that high screen time contributes to adverse cognitive, executive function, and behavior outcomes at ages 6 to 7 years in children born at less than 28 weeks. These findings support the need for clinicians to have heightened awareness of the risks for EPT children and discuss both the benefits and risks of screen time with families.Item Effect of Therapeutic Hypothermia Initiated After 6 Hours of Age on Death or Disability Among Newborns With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial(American Medical Association, 2017-10-24) Laptook, Abbot R.; Shankaran, Seetha; Tyson, Jon E.; Munoz, Breda; Bell, Edward F.; Goldberg, Ronald N.; Parikh, Nehal A.; Ambalavanan, Namasivayam; Pedroza, Claudia; Pappas, Athina; Das, Abhik; Chaudhary, Aasma S.; Ehrenkranz, Richard A.; Hensman, Angelita M.; Van Meurs, Krisa P.; Chalak, Lina F.; Hamrick, Shannon E. G.; Sokol, Gregory M.; Walsh, Michele C.; Poindexter, Brenda B.; Faix, Roger G.; Watterberg, Kristi L.; Frantz, Ivan D., III; Guillet, Ronnie; Devaskar, Uday; Truog, William E.; Chock, Valerie Y.; Wyckoff, Myra H.; McGowan, Elisabeth C.; Carlton, David P.; Harmon, Heidi M.; Brumbaugh, Jane E.; Cotten, C. Michael; Sánchez, Pablo J.; Hibbs, Anna Maria; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of MedicineImportance: Hypothermia initiated at less than 6 hours after birth reduces death or disability for infants with hypoxic-ischemic encephalopathy at 36 weeks' or later gestation. To our knowledge, hypothermia trials have not been performed in infants presenting after 6 hours. Objective: To estimate the probability that hypothermia initiated at 6 to 24 hours after birth reduces the risk of death or disability at 18 months among infants with hypoxic-ischemic encephalopathy. Design, Setting, and Participants: A randomized clinical trial was conducted between April 2008 and June 2016 among infants at 36 weeks' or later gestation with moderate or severe hypoxic-ischemic encephalopathy enrolled at 6 to 24 hours after birth. Twenty-one US Neonatal Research Network centers participated. Bayesian analyses were prespecified given the anticipated limited sample size. Interventions: Targeted esophageal temperature was used in 168 infants. Eighty-three hypothermic infants were maintained at 33.5°C (acceptable range, 33°C-34°C) for 96 hours and then rewarmed. Eighty-five noncooled infants were maintained at 37.0°C (acceptable range, 36.5°C-37.3°C). Main Outcomes and Measures: The composite of death or disability (moderate or severe) at 18 to 22 months adjusted for level of encephalopathy and age at randomization. Results: Hypothermic and noncooled infants were term (mean [SD], 39 [2] and 39 [1] weeks' gestation, respectively), and 47 of 83 (57%) and 55 of 85 (65%) were male, respectively. Both groups were acidemic at birth, predominantly transferred to the treating center with moderate encephalopathy, and were randomized at a mean (SD) of 16 (5) and 15 (5) hours for hypothermic and noncooled groups, respectively. The primary outcome occurred in 19 of 78 hypothermic infants (24.4%) and 22 of 79 noncooled infants (27.9%) (absolute difference, 3.5%; 95% CI, -1% to 17%). Bayesian analysis using a neutral prior indicated a 76% posterior probability of reduced death or disability with hypothermia relative to the noncooled group (adjusted posterior risk ratio, 0.86; 95% credible interval, 0.58-1.29). The probability that death or disability in cooled infants was at least 1%, 2%, or 3% less than noncooled infants was 71%, 64%, and 56%, respectively. Conclusions and Relevance: Among term infants with hypoxic-ischemic encephalopathy, hypothermia initiated at 6 to 24 hours after birth compared with noncooling resulted in a 76% probability of any reduction in death or disability, and a 64% probability of at least 2% less death or disability at 18 to 22 months. Hypothermia initiated at 6 to 24 hours after birth may have benefit but there is uncertainty in its effectiveness.Item Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia(Massachusetts Medical Society, 2022-03-24) Watterberg, Kristi L.; Walsh, Michele C.; Li, Lei; Chawla, Sanjay; D’Angio, Carl T.; Goldberg, Ronald N.; Hintz, Susan R.; Laughon, Matthew M.; Yoder, Bradley A.; Kennedy, Kathleen A.; McDavid, Georgia E.; Backstrom-Lacy, Conra; Das, Abhik; Crawford, Margaret M.; Keszler, Martin; Sokol, Gregory M.; Poindexter, Brenda B.; Ambalavanan, Namasivayam; Hibbs, Anna Maria; Truog, William E.; Schmidt, Barbara; Wyckoff, Myra H.; Khan, Amir M.; Garg, Meena; Chess, Patricia R.; Reynolds, Anne M.; Moallem, Mohannad; Bell, Edward F.; Meyer, Lauritz R.; Patel, Ravi M.; Van Meurs, Krisa P.; Cotten, C. Michael; McGowan, Elisabeth C.; Hines, Abbey C.; Merhar, Stephanie; Peralta-Carcelen, Myriam; Wilson-Costello, Deanne E.; Kilbride, Howard W.; DeMauro, Sara B.; Heyne, Roy J.; Mosquera, Ricardo A.; Natarajan, Girija; Purdy, Isabell B.; Lowe, Jean R.; Maitre, Nathalie L.; Harmon, Heidi M.; Hogden, Laurie A.; Adams-Chapman, Ira; Winter, Sarah; Malcolm, William F.; Higgins, Rosemary D.; Eunice Kennedy Shriver NICHD Neonatal Research Network; Pediatrics, School of MedicineBACKGROUND Bronchopulmonary dysplasia is a prevalent complication after extremely preterm birth. Inflammation with mechanical ventilation may contribute to its development. Whether hydrocortisone treatment after the second postnatal week can improve survival without bronchopulmonary dysplasia and without adverse neurodevelopmental effects is unknown. METHODS We conducted a trial involving infants who had a gestational age of less than 30 weeks and who had been intubated for at least 7 days at 14 to 28 days. Infants were randomly assigned to receive either hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days) or placebo. Mandatory extubation thresholds were specified. The primary efficacy outcome was survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age, and the primary safety outcome was survival without moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age. RESULTS We enrolled 800 infants (mean [±SD] birth weight, 715±167 g; mean gestational age, 24.9±1.5 weeks). Survival without moderate or severe bronchopulmonary dysplasia at 36 weeks occurred in 66 of 398 infants (16.6%) in the hydrocortisone group and in 53 of 402 (13.2%) in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Hypertension that was treated with medication occurred more frequently with hydrocortisone than with placebo (4.3% vs. 1.0%). Other adverse events were similar in the two groups. CONCLUSIONS In this trial involving preterm infants, hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01353313.)Item Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial(Wolters Kluwer, 2021) Blakely, Martin L.; Tyson, Jon E.; Lally, Kevin P.; Hintz, Susan R.; Eggleston, Barry; Stevenson, David K.; Besner, Gail E.; Das, Abhik; Ohls, Robin K.; Truog, William E.; Nelin, Leif D.; Poindexter, Brenda B.; Pedroza, Claudia; Walsh, Michele C.; Stoll, Barbara J.; Geller, Rachel; Kennedy, Kathleen A.; Dimmitt, Reed A.; Carlo, Waldemar A.; Cotten, C. Michael; Laptook, Abbot R.; Van Meurs, Krisa P.; Calkins, Kara L.; Sokol, Gregory M.; Sanchez, Pablo J.; Wyckoff, Myra H.; Patel, Ravi M.; Frantz, Ivan D., III.; Shankaran, Seetha; D'Angio, Carl T.; Yoder, Bradley A.; Bell, Edward F.; Watterberg, Kristi L.; Martin, Colin A.; Harmon, Carroll M.; Rice, Henry; Kurkchubasche, Arlet G.; Sylvester, Karl; Dunn, James C.Y.; Markel, Troy A.; Diesen, Diana L.; Bhatia, Amina M.; Flake, Alan; Chwals, Walter J.; Brown, Rebeccah; Bass, Kathryn D.; St. Peter, Shawn D.; Shanti, Christina M.; Pegoli, Walter, Jr.; Skarda, David; Shilyansky, Joel; Lemon, David G.; Mosquera, Ricardo A.; Peralta-Carcelen, Myriam; Goldstein, Ricki F.; Vohr, Betty R.; Purdy, Isabell B.; Hines, Abbey C.; Maitre, Nathalie L.; Heyne, Roy J.; DeMauro, Sara B.; McGowan, Elisabeth C.; Yolton, Kimberly; Kilbride, Howard W.; Natarajan, Girija; Yost, Kelley; Winter, Sarah; Colaizy, Tarah T.; Laughon, Matthew M.; Lakshminrusimha, Satyanarayana; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health; Human Development Neonatal Research Network; Pediatrics, School of MedicineObjective: The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). Summary background data: The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown. Methods: We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches. Results: Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%. Conclusions: There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.Item Preterm Neuroimaging and School-Age Cognitive Outcomes(American Academy of Pediatrics, 2018-07) Hintz, Susan R.; Vohr, Betty R.; Bann, Carla M.; Taylor, H. Gerry; Das, Abhik; Gustafson, Kathryn E.; Yolton, Kimberly; Watson, Victoria E.; Lowe, Jean; DeAnda, Maria Elena; Ball, M. Bethany; Finer, Neil N.; Van Meurs, Krisa P.; Shankaran, Seetha; Pappas, Athina; Barnes, Patrick D.; Bulas, Dorothy; Newman, Jamie E.; Wilson-Costello, Deanne E.; Heyne, Roy J.; Harmon, Heidi M.; Peralta-Carcelen, Myriam; Adams-Chapman, Ira; Duncan, Andrea Freeman; Fuller, Janell; Vaucher, Yvonne E.; Colaizy, Tarah T.; Winter, Sarah; McGowan, Elisabeth C.; Goldstein, Ricki F.; Higgins, Rosemary D.; Pediatrics, School of MedicineBACKGROUND AND OBJECTIVES: Children born extremely preterm are at risk for cognitive difficulties and disability. The relative prognostic value of neonatal brain MRI and cranial ultrasound (CUS) for school-age outcomes remains unclear. Our objectives were to relate near-term conventional brain MRI and early and late CUS to cognitive impairment and disability at 6 to 7 years among children born extremely preterm and assess prognostic value. METHODS: A prospective study of adverse early and late CUS and near-term conventional MRI findings to predict outcomes at 6 to 7 years including a full-scale IQ (FSIQ) <70 and disability (FSIQ <70, moderate-to-severe cerebral palsy, or severe vision or hearing impairment) in a subgroup of Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial enrollees. Stepwise logistic regression evaluated associations of neuroimaging with outcomes, adjusting for perinatal-neonatal factors. RESULTS: A total of 386 children had follow-up. In unadjusted analyses, severity of white matter abnormality and cerebellar lesions on MRI and adverse CUS findings were associated with outcomes. In full regression models, both adverse late CUS findings (odds ratio [OR] 27.9; 95% confidence interval [CI] 6.0-129) and significant cerebellar lesions on MRI (OR 2.71; 95% CI 1.1-6.7) remained associated with disability, but only adverse late CUS findings (OR 20.1; 95% CI 3.6-111) were associated with FSIQ <70. Predictive accuracy of stepwise models was not substantially improved with the addition of neuroimaging. CONCLUSIONS: Severe but rare adverse late CUS findings were most strongly associated with cognitive impairment and disability at school age, and significant cerebellar lesions on MRI were associated with disability. Near-term conventional MRI did not substantively enhance prediction of severe early school-age outcomes.Item Screening for Autism Spectrum Disorders in Extremely Preterm Infants(Wolters Kluwer, 2012) Stephens, Bonnie E.; Bann, Carla M.; Watson, Victoria E.; Sheinkopf, Stephen J.; Peralta-Carcelen, Myriam; Bodnar, Anna; Yolton, Kimberly; Goldstein, Ricki F.; Dusick, Anna M.; Wilson-Costello, Deanne E.; Acarregui, Michael J.; Pappas, Athina; Adams-Chapman, Ira; McGowan, Elisabeth C.; Heyne, Roy J.; Hintz, Susan R.; Ehrenkranz, Richard A.; Fuller, Janell; Das, Abhik; Higgins, Rosemary D.; Vohr, Betty R.; Pediatrics, School of MedicineBackground: Extremely preterm (EP) infants screen positive for autism spectrum disorders (ASD) at high rates. However, it is not clear whether this is because of high rates of ASD in EPs or to high rates of false-positive screens for ASD in children with a high rate of underlying neurodevelopmental impairments. Combining a parent questionnaire designed to distinguish developmental delay from ASD with direct observation of infant behavior may more accurately screen for ASD in EPs. Objectives: To determine rates of positive screen for ASD at 18 to 22 months(m) in EPs using 3 screens; to determine factors associated with a positive screen. Methods: Five hundred fifty-four infants born <27 weeks were screened at 18 to 22 m using the Pervasive Developmental Disorders Screening test, second edition Stage 2, and the response to name and response to joint attention items from the Autism Diagnostic Observation Schedule. Infants with severe cerebral palsy, deafness, and blindness were excluded. Associations between positive screen and neonatal/ infant characteristics were determined. Results: Of 554 infants, 113 (20%) had ≥ 1 positive screen. 10% had a positive Pervasive Developmental Disorders Screening test, second edition, 6% response to name, 9% response to joint attention; in only 1 % all 3 screens were positive. Positive screen was associated with male gender, more hospital days, white race, lower maternal education, abnormal behavioral scores, and cognitive/ language delay. Conclusions: The use of 3 screens for ASD in EPs results in higher screen positive rates than use of 1 screen alone. Diagnostic confirmation is needed before true rates of ASD in EPs are known.