Effect of estradiol and progesterone replacement on bronchopulmonary dysplasia in extremely preterm infants

Andreas Trotter ^1*, Ludwig Maier ², Martina Kron ² and Frank Pohlandt ²

¹ University of Bonn, Germany
² University of Ulm, Germany

^* To whom correspondence should be addressed. E-mail: andreas.trotter{at}web.de.

Accepted 4 August 2006

Abstract

Objective: To study whether postnatal replacement of E2 and P may help to prevent bronchopulmonary dysplasia (BPD).

Methods: This randomized placebo-controlled double-blind study enrolled 83 infants less than 29 weeks gestational age and 1000g birth-weight requiring mechanical ventilation within 12 hrs after birth. Estradiol (2.5 mg/kg/day) and P (22.5 mg/kg/day) was administered 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 E2 or P. A replacement period of at least 2 but not more than 4 weeks was strived for and defined as 'According to Protocol' (ATP). The primary outcome was the incidence of BPD or death.

Results: The median birth weight was 670g (min- max: 400-990g) and the gestational age 25.0 weeks (23.1- 28.1). 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 ATP 32% (9 of 28) in the Placebo group and 14% (3 of 21) in the ESTRA-PRO group developed BPD (p=0.08).

Conclusion: Replacement of E2 and P was not effective for prevention of BPD or death in extremely preterm born infants. Better powered trials are needed to evaluate this new approach.

Keywords: bronchopulmonary, estradiol, preterm, progesterone, replacement

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