Document Detail


Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial.
MedLine Citation:
PMID:  15574629     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Pediatrics     Volume:  114     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-12-02     Completed Date:  2005-04-05     Revised Date:  2013-02-07    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1649-57     Citation Subset:  AIM; IM    
Affiliation:
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:
Adrenal Insufficiency / 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:
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:
50-23-7/Hydrocortisone
Comments/Corrections
Comment In:
Pediatrics. 2005 May;115(5):1446-7; author reply 1447   [PMID:  15867074 ]
Pediatrics. 2004 Dec;114(6):1670-1   [PMID:  15574631 ]

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