Browsing by Author "Patel, Ravi M."

Now showing 1 - 5 of 5
  • Thumbnail Image
    Item
    Early Brain and Abdominal Oxygenation in Extremely Low Birth Weight Infants
    (Springer Nature, 2022) Chock, Valerie Y.; Smith, Emily; Tan, Sylvia; Ball, M. Bethany; Das, Abhik; Hintz, Susan R.; Kirpalani, Haresh; Bell, Edward F.; Chalak, Lina F.; Cotten, C. Michael; Widness, John A.; Kennedy, Kathleen A.; Ohls, Robin K.; Seabrook, Ruth B.; Patel, Ravi M.; Laptook, Abbot R.; Mancini, Toni; Sokol, Gregory M.; Walsh, Michele C.; Yoder, Bradley A.; Poindexter, Brenda B.; Chawla, Sanjay; D’Angio, Carl T.; Higgins, Rosemary D.; Van Meurs, Krisa P.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of Medicine
    Background: Extremely low birth weight (ELBW) infants are at risk for end-organ hypoxia and ischemia. Regional tissue oxygenation of the brain and gut as monitored with near-infrared spectroscopy (NIRS) may change with postnatal age, but normal ranges are not well defined. Methods: A prospective study of ELBW preterm infants utilized NIRS monitoring to assess changes in cerebral and mesenteric saturation (Csat and Msat) over the first week after birth. This secondary study of a multicenter trial comparing hemoglobin transfusion thresholds assessed cerebral and mesenteric fractional tissue oxygen extraction (cFTOE and mFTOE) and relationships with perinatal variables. Results: In 124 infants, both Csat and Msat declined over the first week, with a corresponding increase in oxygen extraction. With lower gestational age, lower birth weight, and 5-min Apgar score ≤5, there was a greater increase in oxygen extraction in the brain compared to the gut. Infants managed with a lower hemoglobin transfusion threshold receiving ≥2 transfusions in the first week had the lowest Csat and highest cFTOE (p < 0.001). Conclusion: Brain oxygen extraction preferentially increased in more immature and anemic preterm infants. NIRS monitoring may enhance understanding of cerebral and mesenteric oxygenation patterns and inform future protective strategies in the preterm ELBW population. Impact: Simultaneous monitoring of cerebral and mesenteric tissue saturation demonstrates the balance of oxygenation between preterm brain and gut and may inform protective strategies. Over the first week, oxygen saturation of the brain and gut declines as oxygen extraction increases. A low hemoglobin transfusion threshold is associated with lower cerebral saturation and higher cerebral oxygen extraction compared to a high hemoglobin transfusion threshold, although this did not translate into clinically relevant differences in the TOP trial primary outcome. Greater oxygen extraction by the brain compared to the gut occurs with lower gestational age, lower birth weight, and 5-min Apgar score ≤5.
  • Thumbnail Image
    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 Medicine
    Background: 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.
  • Thumbnail Image
    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 Medicine
    BACKGROUND 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.)
  • Thumbnail Image
    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 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.
  • Thumbnail Image
    Item
    Tissue Oxygenation Changes After Transfusion and Outcomes in Preterm Infants: A Secondary Near-Infrared Spectroscopy Study of the Transfusion of Prematures Randomized Clinical Trial (TOP NIRS)
    (American Medical Association, 2023-09-05) Chock, Valerie Y.; Kirpalani, Haresh; Bell, Edward F.; Tan, Sylvia; Hintz, Susan R.; Ball, M. Bethany; Smith, Emily; Das, Abhik; Loggins, Yvonne C.; Sood, Beena G.; Chalak, Lina F.; Wyckoff, Myra H.; Kicklighter, Stephen D.; Kennedy, Kathleen A.; Patel, Ravi M.; Carlo, Waldemar A.; Johnson, Karen J.; Watterberg, Kristi L.; Sánchez, Pablo J.; Laptook, Abbot R.; Seabrook, Ruth B.; Cotten, C. Michael; Mancini, Toni; Sokol, Gregory M.; Ohls, Robin K.; Hibbs, Anna Maria; Poindexter, Brenda B.; Reynolds, Anne Marie; DeMauro, Sara B.; Chawla, Sanjay; Baserga, Mariana; Walsh, Michele C.; Higgins, Rosemary D.; Van Meurs, Krisa P.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of Medicine
    Importance: Preterm infants with varying degrees of anemia have different tissue oxygen saturation responses to red blood cell (RBC) transfusion, and low cerebral saturation may be associated with adverse outcomes. Objective: To determine whether RBC transfusion in preterm infants is associated with increases in cerebral and mesenteric tissue saturation (Csat and Msat, respectively) or decreases in cerebral and mesenteric fractional tissue oxygen extraction (cFTOE and mFTOE, respectively) and whether associations vary based on degree of anemia, and to investigate the association of Csat with death or neurodevelopmental impairment (NDI) at 22 to 26 months corrected age. Design, setting, and participants: This was a prospective observational secondary study conducted among a subset of infants between August 2015 and April 2017 in the Transfusion of Prematures (TOP) multicenter randomized clinical trial at 16 neonatal intensive care units of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Preterm neonates with gestational age 22 to 28 weeks and birth weight 1000 g or less were randomized to higher or lower hemoglobin thresholds for transfusion. Data were analyzed between October 2020 and May 2022. Interventions: Near-infrared spectroscopy monitoring of Csat and Msat. Main outcomes and measures: Primary outcomes were changes in Csat, Msat, cFTOE, and mFTOE after transfusion between hemoglobin threshold groups, adjusting for age at transfusion, gestational age, birth weight stratum, and center. Secondary outcome at 22 to 26 months was death or NDI defined as cognitive delay (Bayley Scales of Infant and Toddler Development-III score <85), cerebral palsy with Gross Motor Function Classification System level II or greater, or severe vision or hearing impairment. Results: A total of 179 infants (45 [44.6%] male) with mean (SD) gestational age 25.9 (1.5) weeks were enrolled, and valid data were captured from 101 infants during 237 transfusion events. Transfusion was associated with a significant increase in mean Csat of 4.8% (95% CI, 2.7%-6.9%) in the lower-hemoglobin threshold group compared to 2.7% (95% CI, 1.2%-4.2%) in the higher-hemoglobin threshold group, while mean Msat increased 6.7% (95% CI, 2.4%-11.0%) vs 5.6% (95% CI, 2.7%-8.5%). Mean cFTOE and mFTOE decreased in both groups to a similar extent. There was no significant change in peripheral oxygen saturation (SpO2) in either group (0.2% vs -0.2%). NDI or death occurred in 36 infants (37%). Number of transfusions with mean pretransfusion Csat less than 50% was associated with NDI or death (odds ratio, 2.41; 95% CI, 1.08-5.41; P = .03). Conclusions and relevance: In this secondary study of the TOP randomized clinical trial, Csat and Msat were increased after transfusion despite no change in SpO2. Lower pretransfusion Csat may be associated with adverse outcomes, supporting further investigation of targeted tissue saturation monitoring in preterm infants with anemia.