Browsing by Author "Vohr, Betty R."
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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 Characteristics of extremely low birth weight infant survivors with unimpaired outcomes at 30 months of age(Springer Nature, 2013) Kumar, Praveen; Shankaran, Seetha; Ambalavanan, Namasivayam; Kendrick, Douglas E.; Pappas, Athina; Vohr, Betty R.; Poindexter, Brenda B.; Das, Abhik; Higgins, Rosemary D.; NICHD Neonatal Research Network; Pediatrics, School of MedicineObjective: To evaluate characteristics of unimpaired outcome in extremely low-birth-weight (ELBW) survivors. Study design: ELBW infants (n=714) with 30 months' assessments were analyzed. Logistic regression was used to develop a model for the binary outcome of unimpaired versus impaired outcome. Result: Thirty-three percent of infants had an unimpaired outcome. Seventeen percent of ELBW survivors had a Bayley II Mental Developmental Index score of ≥ 101 and 2% had a score of ≥ 116. Female gender, use of antenatal steroids (ANS), maternal education ≥ high school and the absence of major neonatal morbidities were independent predictors of unimpaired outcome. The likelihood of an unimpaired outcome in the presence of major neonatal morbidities was higher in infants exposed to ANS. Conclusion: The majority of unimpaired ELBW survivors had cognitive scores shifted toward the lower end of the normal distribution. Exposure to ANS was associated with higher likelihood of an unimpaired outcome in infants with major neonatal morbidities.Item Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants(Massachusetts Medical Society, 2020-12-01) Kirpalani, Haresh; Bell, Edward F.; Hintz, Susan R.; Tan, Sylvia; Schmidt, Barbara; Chaudhary, Aasma S.; Johnson, Karen J.; Crawford, Margaret M.; Newman, Jamie E.; Vohr, Betty R.; Carlo, Waldemar A.; D'Angio, Carl T.; Kennedy, Kathleen A.; Ohls, Robin K.; Poindexter, Brenda B.; Schibler, Kurt; Whyte, Robin K.; Widness, John A.; Zupancic, John A.F.; Wyckoff, Myra H.; Truog, William E.; Walsh, Michele C.; Chock, Valerie Y.; Laptook, Abbot R.; Sokol, Gregory M.; Yoder, Bradley A.; Patel, Ravi M.; Cotten, C. Michael; Carmen, Melissa F.; Devaskar, Uday; Chawla, Sanjay; Seabrook, Ruth; Higgins, Rosemary D.; Das, Abhik; Pediatrics, School of MedicineBackground: Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia. Methods: We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity. Results: A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively. Conclusions: In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity.Item Improving the Neonatal Research Network Annual Certification for Neurologic Examination of the 18–22 month Child(Elsevier, 2012) Newman, Jamie E.; Bann, Carla M.; Vohr, Betty R.; Dusick, Anna M.; Higgins, Rosemary D.; Follow-Up Study Group of Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of MedicineObjective: To describe the Neonatal Research Network's efforts to improve the certification process for the Follow-Up Study neurologic exam and to evaluate inter-rater agreement before and after two annual training workshops. Study design: The Neonatal Research Network Follow-Up Study is a multi-center observational study that has examined more than 11 500 infants from 1998-2010 and born ≤26 weeks gestational age at 18-22 months corrected age for neurodevelopmental outcome. The percentages of examiners who agreed with the Gold Standard examiner on 4 neurodevelopmental outcomes on the initial training video and a test video were calculated. Consistency among examiners was assessed with the first-order agreement coefficient statistic. Results: Improvements in agreement among examiners occurred between 2009 and 2010 and between initial training and test. Examiner agreement with the Gold Standard during the initial training was 83%-91% in 2009 and 89%-99% in 2010. Examiner agreement on the workshop test video increased from 2009-2010 with agreement reaching 100% for all four neurodevelopmental outcomes examined in 2010. First-order agreement coefficient values for the four neurodevelopmental outcomes on the training videos ranged from 0.64-0.82 in 2009 and 0.77-0.97 in 2010. Conclusions: We demonstrate the importance of annual certification and the benefits of evaluation and revision of certification protocols to achieve high levels of confidence in neurodevelopmental study outcomes for multi-center networks.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 Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial(Springer Nature, 2021) Adams-Chapman, Ira; Watterberg, Kristi L.; Nolen, Tracy L.; Hirsch, Shawn; Cole, Carol A.; Cotten, C. Michael; Oh, William; Poindexter, Brenda B.; Zaterka-Baxter, Kristin M.; Das, Abhik; Backstrom Lacy, Conra; Scorsone, Ann Marie; Duncan, Andrea F.; DeMauro, Sara B.; Goldstein, Ricki F.; Colaizy, Tarah T.; Wilson-Costello, Deanne E.; Purdy, Isabell B.; Hintz, Susan R.; Heyne, Roy J.; Myers, Gary J.; Fuller, Janell; Merhar, Stephanie; Harmon, Heidi M.; Peralta-Carcelen, Myriam; Kilbride, Howard W.; Maitre, Nathalie L.; Vohr, Betty R.; Natarajan, Girija; Mintz-Hittner, Helen; Quinn, Graham E.; Wallace, David K.; Olson, Richard J.; Orge, Faruk H.; Tsui, Irena; Gaynon, Michael; Hutchinson, Amy K.; He, Yu-Guang; Winter, Timothy W.; Yang, Michael B.; Haider, Kathryn M.; Cogen, Martin S.; Hug, Denise; Bremer, Don L.; Donahue, John P.; Lucas, William R.; Phelps, Dale L.; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of MedicineObjective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.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.