| Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial. | |
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MedLine Citation:
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PMID: 15574629 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Infants developing bronchopulmonary dysplasia (BPD) show decreased cortisol response to adrenocorticotropic hormone. A pilot study of low-dose hydrocortisone therapy for prophylaxis of early adrenal insufficiency showed improved survival without BPD at 36 weeks' postmenstrual age, particularly in infants exposed to histologic chorioamnionitis. METHODS: Mechanically ventilated infants with birth weights of 500 to 999 g were enrolled into this multicenter, randomized, masked trial between 12 and 48 hours of life. Patients received placebo or hydrocortisone, 1 mg/kg per day for 12 days, then 0.5 mg/kg per day for 3 days. BPD at 36 weeks' postmenstrual age was defined clinically (receiving supplemental oxygen) and physiologically (supplemental oxygen required for O2 saturation > or =90%). RESULTS: Patient enrollment was stopped at 360 patients because of an increase in spontaneous gastrointestinal perforation in the hydrocortisone-treated group. Survival without BPD was similar, defined clinically or physiologically, as were mortality, head circumference, and weight at 36 weeks. For patients exposed to histologic chorioamnionitis (n = 149), hydrocortisone treatment significantly decreased mortality and increased survival without BPD, defined clinically or physiologically. After treatment, cortisol values and response to adrenocorticotropic hormone were similar between groups. Hydrocortisone-treated infants receiving indomethacin had more gastrointestinal perforations than placebo-treated infants receiving indomethacin, suggesting an interactive effect. CONCLUSIONS: Prophylaxis of early adrenal insufficiency did not improve survival without BPD in the overall study population; however, treatment of chorioamnionitis-exposed infants significantly decreased mortality and improved survival without BPD. Low-dose hydrocortisone therapy did not suppress adrenal function or compromise short-term growth. The combination of indomethacin and hydrocortisone should be avoided. |
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Authors:
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Kristi L Watterberg; Jeffrey S Gerdes; Cynthia H Cole; Susan W Aucott; Elizabeth H Thilo; Mark C Mammel; Robert J Couser; Jeffery S Garland; Henry J Rozycki; Corinne L Leach; Conra Backstrom; Michele L Shaffer |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Pediatrics Volume: 114 ISSN: 1098-4275 ISO Abbreviation: Pediatrics Publication Date: 2004 Dec |
Date Detail:
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Created Date: 2004-12-02 Completed Date: 2005-04-05 Revised Date: 2013-02-07 |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: United States |
Other Details:
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Languages: eng Pagination: 1649-57 Citation Subset: AIM; IM |
Affiliation:
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Division of Neonatology, Department of Pediatrics/Neonatology, University of New Mexico School of Medicine, MSC10 5590, Albuquerque, NM 87131-0001, USA. kwatterberg@salud.unm.edu |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adrenal Insufficiency
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prevention & control* Bronchopulmonary Dysplasia / prevention & control* Chorioamnionitis Disease-Free Survival Female Humans Hydrocortisone / adverse effects, therapeutic use* Infant, Newborn Infant, Premature Infant, Premature, Diseases / chemically induced, prevention & control* Infant, Very Low Birth Weight* Intestinal Perforation / chemically induced Male Pregnancy Stomach / drug effects Treatment Failure |
| Grant Support | |
ID/Acronym/Agency:
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5M01 RROO997/RR/NCRR NIH HHS; M01 RROOO54/RR/NCRR NIH HHS; M01-RROOO69/RR/NCRR NIH HHS; R01 HD038540/HD/NICHD NIH HHS; R01-HD38540/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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50-23-7/Hydrocortisone |
| Comments/Corrections | |
Comment In:
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Pediatrics. 2005 May;115(5):1446-7; author reply 1447
[PMID:
15867074
]
Pediatrics. 2004 Dec;114(6):1670-1 [PMID: 15574631 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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