Effect of Hydrocortisone Therapy Initiated 7 to 14 Days After Birth on Mortality or Bronchopulmonary Dysplasia Among Very Preterm Infants Receiving Mechanical Ventilation
| Autor: | Onland, W., Cools, F., Kroon, A., Rademaker, K., Merkus, M.P., Dijk, P.H., Straaten, H.L. van, Pas, A.B.T., Mohns, T., Bruneel, E., Heijst, A.F. van, Kramer, B.W., Debeer, A., Zonnenberg, I., Marechal, Y., Blom, H., Plaskie, K., Offringa, M., Kaam, A.H. van, Nuytemans, D.H., Loo, M.V. de, Kemper, E.M., Vereeck, I., Heide-Jalving, M. van der, Kort, E. de, Cavartorta, E., Rassart, A., Eerdekens, A., Stuijvenberg, M., Matthijsse, R., Boode, W. de, Niemarkt, H., Hattum, I. van, Jebbink, L.G., Mulder-de Tollenaer, S.M., Tan, R., Theyskens, C., Weissenbruch, M. van, Dierckx, E., Rigo, V., Vrijlandt, E., Tweel, I. van der, Baal, C. van, Wildt, S. de, STOP-BPD Study Grp, Data Safety Monitoring Comm |
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| Přispěvatelé: | Pediatric surgery, Amsterdam Reproduction & Development (AR&D), Kindergeneeskunde, MUMC+: MA Medische Staf Kindergeneeskunde (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, STOP-BPD Study Grp, Data Safety Monitoring Comm, Clinical sciences, Growth and Development, Neonatology, Pediatrics, Groningen Research Institute for Asthma and COPD (GRIAC), ARD - Amsterdam Reproduction and Development, APH - Methodology, APH - Quality of Care, Other Research, Clinical Research Unit, APH - Health Behaviors & Chronic Diseases |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Hydrocortisone
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] Anti-Inflammatory Agents CHILDREN Infant Premature Diseases 01 natural sciences law.invention 0302 clinical medicine Randomized controlled trial law Pregnancy Medicine Infant Very Low Birth Weight 030212 general & internal medicine Treatment Failure Original Investigation Bronchopulmonary Dysplasia Incidence TREAT Gestational age General Medicine Female Life Sciences & Biomedicine Infant Premature medicine.medical_specialty Birth weight Placebo Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] Time-to-Treatment 03 medical and health sciences MORBIDITY Medicine General & Internal All institutes and research themes of the Radboud University Medical Center Double-Blind Method General & Internal Medicine Intensive care Internal medicine Intensive Care Units Neonatal Humans 0101 mathematics Science & Technology business.industry Other Research Radboud Institute for Health Sciences [Radboudumc 0] 010102 general mathematics Postmenstrual Age Infant Newborn PREVENT Odds ratio medicine.disease Respiration Artificial Bronchopulmonary dysplasia RISK-FACTORS Human medicine POSTNATAL CORTICOSTEROIDS Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] business |
| Zdroj: | Journal of the American Medical Association, 321(4), 354-363 JAMA-Journal of the American Medical Association, 321(4), 354-363. American Medical Association JAMA : the journal of the American Medical Association Jama : Journal of the American Medical Association, 321, 354-363 Jama : Journal of the American Medical Association, 321, 4, pp. 354-363 Onland, W, Cools, F, Kroon, A, Rademaker, K, Merkus, M P, Dijk, P H, van Straaten, H L, te Pas, A B, Mohns, T, Bruneel, E, van Heijst, A F, Kramer, B W, Debeer, A, Zonnenberg, I, Marechal, Y, Blom, H, Plaskie, K, Offringa, M & van Kaam, A H 2019, ' Effect of Hydrocortisone Therapy Initiated 7 to 14 Days after Birth on Mortality or Bronchopulmonary Dysplasia among Very Preterm Infants Receiving Mechanical Ventilation: A Randomized Clinical Trial ', JAMA-Journal of the American Medical Association, vol. 321, no. 4, pp. 354-363 . https://doi.org/10.1001/jama.2018.21443 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 321(4), 354-363. AMER MEDICAL ASSOC JAMA, 321(4), 354-363. American Medical Association |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2018.21443 |
| Popis: | IMPORTANCE: Dexamethasone initiated after the first week of life reduces the rate of death or bronchopulmonary dysplasia (BPD) but may cause long-term adverse effects in very preterm infants. Hydrocortisone is increasingly used as an alternative, but evidence supporting its efficacy and safety is lacking. OBJECTIVE: To assess the effect of hydrocortisone initiated between 7 and 14 days after birth on death or BPD in very preterm infants. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, placebo-controlled randomized trial conducted in 19 neonatal intensive care units in the Netherlands and Belgium from November 15, 2011, to December 23, 2016, among preterm infants with a gestational age of less than 30 weeks and/or birth weight of less than 1250 g who were ventilator dependent between 7 and 14 days of life, with follow-up to hospital discharge ending December 12, 2017. INTERVENTIONS: Infants were randomly assigned to receive a 22-day course of systemic hydrocortisone (cumulative dose, 72.5 mg/kg) (n = 182) or placebo (n = 190). MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of death or BPD assessed at 36 weeks' postmenstrual age. Twenty-nine secondary outcomes were analyzed up to hospital discharge, including death and BPD at 36 weeks' postmenstrual age. RESULTS: Among 372 patients randomized (mean gestational age, 26 weeks; 55% male), 371 completed the trial; parents withdrew consent for 1 child treated with hydrocortisone. Death or BPD occurred in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 infants (73.7%) randomized to placebo (adjusted risk difference, -3.6% [95% CI, -12.7% to 5.4%]; adjusted odds ratio, 0.87 [95% CI, 0.54-1.38]; P = .54). Of 29 secondary outcomes, 8 showed significant differences, including death at 36 weeks' postmenstrual age (15.5% with hydrocortisone vs 23.7% with placebo; risk difference, -8.2% [95% CI, -16.2% to -0.1%]; odds ratio, 0.59 [95% CI, 0.35-0.995]; P = .048). Twenty-one outcomes showed nonsignificant differences, including BPD (55.2% with hydrocortisone vs 50.0% with placebo; risk difference, 5.2% [95% CI, -4.9% to 15.2%]; odds ratio, 1.24 [95% CI, 0.82-1.86]; P = .31). Hyperglycemia requiring insulin therapy was the only adverse effect reported more often in the hydrocortisone group (18.2%) than in the placebo group (7.9%). CONCLUSIONS AND RELEVANCE: Among mechanically ventilated very preterm infants, administration of hydrocortisone between 7 and 14 days after birth, compared with placebo, did not improve the composite outcome of death or BPD at 36 weeks' postmenstrual age. These findings do not support the use of hydrocortisone for this indication. TRIAL REGISTRATION: Netherlands National Trial Register Identifier: NTR2768. ispartof: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION vol:321 issue:4 pages:354-363 ispartof: location:United States status: published |
| Databáze: | OpenAIRE |
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