title: Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial.
abstract: BACKGROUND
  Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants.
  
  
  METHODS
  The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis.
  
  
  CONCLUSIONS
  This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants.
authors: Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
authors: Wes
authors: W
authors: Onland
authors: Martin
authors: M
authors: Offringa
authors: Filip
authors: F
authors: Cools
authors: Anne P
authors: AP
authors: De Jaegere
authors: Karin
authors: K
authors: Rademaker
authors: Henry
authors: H
authors: Blom
authors: Eric
authors: E
authors: Cavatorta
authors: Anne
authors: A
authors: Debeer
authors: Peter H
authors: PH
authors: Dijk
authors: Arno F
authors: AF
authors: van Heijst
authors: Boris W
authors: BW
authors: Kramer
authors: Andre A
authors: AA
authors: Kroon
authors: Thilo
authors: T
authors: Mohns
authors: Henrica L
authors: HL
authors: van Straaten
authors: Arjan B
authors: AB
authors: te Pas
authors: Claire
authors: C
authors: Theyskens
authors: Mirjam M
authors: MM
authors: van Weissenbruch
authors: Anton H
authors: AH
authors: van Kaam
mesh_terms: D001530:Belgium / Q000453:epidemiology; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology / Q000378:metabolism / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004333:Drug Administration Routes; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage* / Q000493:pharmacokinetics; D015994:Incidence; D007226:Infant Mortality / Q000639:trends; D007231:Infant, Newborn; D007234:Infant, Premature; D009426:Netherlands / Q000453:epidemiology; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D006854:Hydrocortisone