Browsing by Author "Stoll, Barbara J."

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    Definitions of Cardiovascular Insufficiency and Relation to Outcomes in Critically Ill Newborn Infants
    (Thieme, 2015-09) Fernandez, Erika; Watterberg, Kristi L.; Faix, Roger G.; Yoder, Bradley A.; Walsh, Michele C.; Lacy, Conra Backstrom; Osborne, Karen A.; Das, Abhik; Kendrick, Douglas E.; Stoll, Barbara J.; Poindexter, Brenda B.; Laptook, Abbot R.; Kennedy, Kathleen A.; Schibler, Kurt; Bell, Edward F.; Van Meurs, Krisa P.; Frantz, Ivan D. III; Goldberg, Ronald N.; Shankaran, Seetha; Carlo, Waldemar A.; Ehrenkranz, Richard A.; Sánchez, Pablo J.; Higgins, Rosemary D.; Department of Pediatrics, Indiana University School of Medicine
    Background We previously reported on the overall incidence, management, and outcomes in infants with cardiovascular insufficiency (CVI). However, there are limited data on the relationship of the specific different definitions of CVI to short-term outcomes in term and late preterm newborn infants. Objective This study aims to evaluate how four definitions of CVI relate to short-term outcomes and death. Study Design The previously reported study was a multicenter, prospective cohort study of 647 infants ≥ 34 weeks gestation admitted to a Neonatal Research Network (NRN) newborn intensive care unit (NICU) and mechanically ventilated (MV) during their first 72 hours. The relationship of five short-term outcomes at discharge and four different definitions of CVI were further analyzed. Results All the four definitions were associated with greater number of days on MV and days on O2. The definition using a threshold blood pressure (BP) measurement alone was not associated with days of full feeding, days in the NICU or death. The definition based on the treatment of CVI was associated with all the outcomes including death. Conclusions The definition using a threshold BP alone was not consistently associated with adverse short-term outcomes. Using only a threshold BP to determine therapy may not improve outcomes.
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    Developmental Outcomes of Very Preterm Infants with Tracheostomies
    (Elsevier, 2014-06) DeMauro, Sara B.; D'Agostino, Jo Ann; Bann, Carla; Bernbaum, Judy; Gerdes, Marsha; Bell, Edward F.; Carlo, Waldemar A.; D'Angio, Carl; Das, Abhik; Higgins, Rosemary; Hintz, Susan R.; Laptook, Abbot R.; Natarajan, Girija; Nelin, Leif; Poindexter, Brenda B.; Sanchez, Pablo J.; Shankaran, Seetha; Stoll, Barbara J.; Truog, William; Van Meurs, Krisa P.; Vohr, Betty; Walsh, Michele C.; Kirpalani, Haresh; Department of Pediatrics, IU School of Medicine
    Objectives To evaluate the neurodevelopmental outcomes of very preterm (<30 weeks) infants who underwent tracheostomy. Study design Retrospective cohort study from 16 centers of the NICHD Neonatal Research Network over 10 years (2001-2011). Infants who survived to at least 36 weeks (N=8,683), including 304 infants with tracheostomies, were studied. Primary outcome was death or neurodevelopmental impairment (NDI, a composite of one or more of: developmental delay, neurologic impairment, profound hearing loss, severe visual impairment) at a corrected age of 18-22 months. Outcomes were compared using multiple logistic regression. We assessed impact of timing, by comparing outcomes of infants who underwent tracheostomy before and after 120 days of life. Results Tracheostomies were associated with all neonatal morbidities examined, and with most adverse neurodevelopmental outcomes. Death or NDI occurred in 83% of infants with tracheostomies and 40% of those without [odds ratio (OR) adjusted for center 7.0 (95%CI, 5.2-9.5)]. After adjustment for potential confounders, odds of death or NDI remained higher [OR 3.3 (95%CI, 2.4-4.6)], but odds of death alone were lower [OR 0.4 (95%CI, 0.3-0.7)], among infants with tracheostomies. Death or NDI was lower in infants who received their tracheostomies before, rather than after, 120 days of life [adjusted OR 0.5 (95%CI, 0.3-0.9)]. Conclusions Tracheostomy in preterm infants is associated with adverse developmental outcomes, and cannot mitigate the significant risk associated with many complications of prematurity. These data may inform counseling about tracheostomy in this vulnerable population.
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    Early-Onset Neonatal Sepsis 2015 to 2017, the Rise of Escherichia coli, and the Need for Novel Prevention Strategies
    (American Medical Association, 2020-07) Stoll, Barbara J.; Puopolo, Karen M.; Hansen, Nellie I.; Sánchez, Pablo J.; Bell, Edward F.; Carlo, Waldemar A.; Cotten, C. Michael; D’Angio, Carl T.; Kazzi, S. Nadya J.; Poindexter, Brenda B.; Van Meurs, Krisa P.; Hale, Ellen C.; Collins, Monica V.; Das, Abhik; Baker, Carol J.; Wyckoff, Myra H.; Yoder, Bradley A.; Watterberg, Kristi L.; Walsh, Michele C.; Devaskar, Uday; Laptook, Abbot R.; Sokol, Gregory M.; Schrag, Stephanie J.; Higgins, Rosemary D.; Pediatrics, School of Medicine
    Importance: Early-onset sepsis (EOS) remains a potentially fatal newborn condition. Ongoing surveillance is critical to optimize prevention and treatment strategies. Objective: To describe the current incidence, microbiology, morbidity, and mortality of EOS among a cohort of term and preterm infants. Design, setting, and participants: This prospective surveillance study included a cohort of infants born at a gestational age (GA) of at least 22 weeks and birth weight of greater than 400 g from 18 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network from April 1, 2015, to March 31, 2017. Data were analyzed from June 14, 2019, to January 28, 2020. Main outcomes and measures: Early-onset sepsis defined by isolation of pathogenic species from blood or cerebrospinal fluid culture within 72 hours of birth and antibiotic treatment for at least 5 days or until death. Results: A total of 235 EOS cases (127 male [54.0%]) were identified among 217 480 newborns (1.08 [95% CI, 0.95-1.23] cases per 1000 live births). Incidence varied significantly by GA and was highest among infants with a GA of 22 to 28 weeks (18.47 [95% CI, 14.57-23.38] cases per 1000). No significant differences in EOS incidence were observed by sex, race, or ethnicity. The most frequent pathogens were Escherichia coli (86 [36.6%]) and group B streptococcus (GBS; 71 [30.2%]). E coli disease primarily occurred among preterm infants (68 of 131 [51.9%]); GBS disease primarily occurred among term infants (54 of 104 [51.9%]), with 24 of 45 GBS cases (53.3%) seen in infants born to mothers with negative GBS screening test results. Intrapartum antibiotics were administered to 162 mothers (68.9%; 110 of 131 [84.0%] preterm and 52 of 104 [50.0%] term), most commonly for suspected chorioamnionitis. Neonatal empirical antibiotic treatment most frequently included ampicillin and gentamicin. All GBS isolates were tested, but only 18 of 81 (22.2%) E coli isolates tested were susceptible to ampicillin; 6 of 77 E coli isolates (7.8%) were resistant to both ampicillin and gentamicin. Nearly all newborns with EOS (220 of 235 [93.6%]) displayed signs of illness within 72 hours of birth. Death occurred in 38 of 131 infected infants with GA of less than 37 weeks (29.0%); no term infants died. Compared with earlier surveillance (2006-2009), the rate of E coli infection increased among very low-birth-weight (401-1500 g) infants (8.68 [95% CI, 6.50-11.60] vs 5.07 [95% CI, 3.93-6.53] per 1000 live births; P = .008). Conclusions and relevance: In this study, EOS incidence and associated mortality disproportionately occurred in preterm infants. Contemporary cases have demonstrated the limitations of current GBS prevention strategies. The increase in E coli infections among very low-birth-weight infants warrants continued study. Ampicillin and gentamicin remained effective antibiotics in most cases, but ongoing surveillance should monitor antibiotic susceptibilities of EOS pathogens.
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    Incidence, management, and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants
    (Thieme, 2014-11) Fernandez, Erika; Watterberg, Kristi L.; Faix, Roger G.; Yoder, Bradley A.; Walsh, Michele C.; Backstrom Lacy, Conra; Osborne, Karen A.; Das, Abhik; Kendrick, Douglas E.; Stoll, Barbara J.; Poindexter, Brenda B.; Laptook, Abbot R.; Kennedy, Kathleen A.; Schibler, Kurt; Bell, Edward F.; Van Meurs, Krisa P.; Frantz III, Ivan D.; Goldberg, Ronald N.; Shankaran, Seetha; Carlo, Waldemar A.; Ehrenkranz, Richard A.; Sánchez, Pablo J.; Higgins, Rosemary D.; Department of Pediatrics, IU School of Medicine
    OBJECTIVE: The objective of this study was to characterize the incidence, management, and short-term outcomes of cardiovascular insufficiency (CVI) in mechanically ventilated newborns, evaluating four separate prespecified definitions. STUDY DESIGN: Multicenter, prospective cohort study of infants ≥34 weeks gestational age (GA) and on mechanical ventilation during the first 72 hours. CVI was prospectively defined as either (1) mean arterial pressure (MAP) < GA; (2) MAP < GA + signs of inadequate perfusion; (3) any therapy for CVI; or (4) inotropic therapy. Short-term outcomes included death, days on ventilation, oxygen, and to full feedings and discharge. RESULTS: Of 647 who met inclusion criteria, 419 (65%) met ≥1 definition of CVI. Of these, 98% received fluid boluses, 36% inotropes, and 17% corticosteroids. Of treated infants, 46% did not have CVI as defined by a MAP < GA ± signs of inadequate perfusion. Inotropic therapy was associated with increased mortality (11.1 vs. 1.3%; p < 0.05). CONCLUSION: More than half of the infants met at least one definition of CVI. However, almost half of the treated infants met none of the definitions. Inotropic therapy was associated with increased mortality. These findings can help guide the design of future studies of CVI in newborns
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    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 Medicine
    Objective: 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.
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    Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial
    (Elsevier, 2019-01) Shankaran, Seetha; Bell, Edward F.; Laptook, Abbot R.; Saha, Shampa; Newman, Nancy S.; Kazzi, S. Nadya J.; Barks, John; Stoll, Barbara J.; Bara, Rebecca; Gabrio, Jenna; Childs, Kirsten; Das, Abhik; Higgins, Rosemary D.; Carlo, Waldemar A.; Sánchez, Pablo J.; Carlton, David P.; Pavageau, Lara; Malcolm, William F.; D’Angio, Carl T.; Ohls, Robin K.; Poindexter, Brenda B.; Sokol, Gregory M.; Van Meurs, Krisa P.; Colaizy, Tarah T.; Khmour, Ayman; Puopolo, Karen M.; Garg, Meena; Walsh, Michele C.; Pediatrics, School of Medicine
    OBJECTIVE: To assess whether length of hospital stay is decreased among moderately preterm infants weaned from incubator to crib at a lower vs higher weight. STUDY DESIGN: This trial was conducted in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants with gestational ages 29-33 weeks, birthweight <1600 g, and in an incubator were randomly assigned to a weaning weight of 1600 or 1800 g. Within 60 to 100 g of weaning weight, the incubator temperature was decreased by 1.0°C to 1.5°C every 24 hours until 28.0°C. The infants were weaned to the crib following stable temperature at 36.5°C to 37.4°C for 8 to 12 hours. Clothing and bedcoverings were standardized. The primary outcome was length of hospital stay from birth to discharge; secondary outcomes included length of stay and growth velocity from weaning to discharge. Adverse events were monitored. RESULTS: Of 1565 infants screened, 885 were eligible, and 366 enrolled-187 to the 1600-g and 179 to the 1800-g group. Maternal and neonatal characteristics did not differ among weight groups. Length of hospital stay was a median of 43 days in the lower and 41 days in the higher weight group (P = .12). Growth velocity from completion of weaning to discharge was higher in the lower weight group, 13.7 g/kg/day vs 12.8 g/kg/day (P = .005). Groups did not differ in adverse events. CONCLUSIONS: Among moderately preterm neonates, weaning from incubator to crib at a lower weight did not decrease length of stay, but was safe and was accompanied by higher weight gain after weaning.