title: Effect of oestradiol and progesterone replacement on bronchopulmonary dysplasia in extremely preterm infants.
abstract: OBJECTIVE
  To study whether postnatal replacement of oestradiol and progesterone may help to prevent bronchopulmonary dysplasia (BPD).
  
  
  METHODS
  This randomised placebo-controlled double-blind study enrolled 83 infants of <29 weeks gestational age and 1000 g birth weight requiring mechanical ventilation within 12 h after birth. Oestradiol (2.5 mg/kg/day) and progesterone (22.5 mg/kg/day) were given by continuous intravenous infusion of a standard lipid emulsion (15 ml/kg/day) in the replacement group (ESTRA-PRO). The placebo group received the same lipid emulsion without oestradiol or progesterone. A replacement period of at least 2 weeks but not >4 weeks was strived for and defined as "according to protocol". The primary outcome variable was the incidence of BPD or death.
  
  
  RESULTS
  The median birth weight was 670 g (min-max 400-990 g) and the gestational age 25 weeks (23.1-28.1 weeks). The incidence of BPD or death was 48% in the placebo group and 44% in the ESTRA-PRO group (p = 0.38, one-sided testing, intention to treat analysis). In infants treated according to protocol, 32% (9 of 28) in the placebo group and 14% (3 of 21) in the ESTRA-PRO group developed BPD (p = 0.08).
  
  
  CONCLUSIONS
  Replacement of oestradiol and progesterone was not effective for prevention of BPD or death in extremely preterm born infants. Better-powered trials are needed to evaluate this new approach.
authors.affiliation: Section of Neonatology and Pediatric Critical Care Medicine, Children's Hospital, University of Ulm, Ulm, Germany. andreas.trotter@web.de
authors.forename: A
authors.initials: A
authors.lastname: Trotter
authors.forename: L
authors.initials: L
authors.lastname: Maier
authors.forename: M
authors.initials: M
authors.lastname: Kron
authors.forename: F
authors.initials: F
authors.lastname: Pohlandt
mesh_terms: D001724:Birth Weight; D001997:Bronchopulmonary Dysplasia / Q000097:blood / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D011374:Progesterone / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011374:Progesterone; D004958:Estradiol