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Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
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.
Afiliación
  • Watterberg KL; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Walsh MC; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Li L; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Chawla S; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • D'Angio CT; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Goldberg RN; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Hintz SR; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Laughon MM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Yoder BA; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Kennedy KA; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • McDavid GE; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Backstrom-Lacy C; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Das A; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Crawford MM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Keszler M; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Sokol GM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Poindexter BB; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Ambalavanan N; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Hibbs AM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Truog WE; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Schmidt B; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Wyckoff MH; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Khan AM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Garg M; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Chess PR; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Reynolds AM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Moallem M; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Bell EF; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Meyer LR; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Patel RM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Van Meurs KP; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Cotten CM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • McGowan EC; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Hines AC; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Merhar S; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Peralta-Carcelen M; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Wilson-Costello DE; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Kilbride HW; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • DeMauro SB; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Heyne RJ; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Mosquera RA; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Natarajan G; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Purdy IB; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Lowe JR; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Maitre NL; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Harmon HM; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Hogden LA; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Adams-Chapman I; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Winter S; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
  • Malcolm WF; From the University of New Mexico Health Sciences Center, Albuquerque (K.L.W., C.B.-L., J.R.L.); the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.W., A.M.H., D.E.W.-C.), Cincinnati Children's Hospital Medical Center, Department of
N Engl J Med ; 386(12): 1121-1131, 2022 03 24.
Article en En | MEDLINE | ID: mdl-35320643
ABSTRACT

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.).
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Displasia Broncopulmonar / Recien Nacido Prematuro / Hidrocortisona / Glucocorticoides Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans / Newborn Idioma: En Revista: N Engl J Med Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Displasia Broncopulmonar / Recien Nacido Prematuro / Hidrocortisona / Glucocorticoides Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans / Newborn Idioma: En Revista: N Engl J Med Año: 2022 Tipo del documento: Article