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Effect of oestradiol and progesterone replacement on bronchopulmonary dysplasia in extremely preterm infants
1Section of Neonatology and Pediatric Critical Care Medicine, Children's Hospital, University of Ulm, Ulm, Germany. andreas.trotter@web.de
Insights
Postnatal hormone replacement with oestradiol and progesterone did not prevent bronchopulmonary dysplasia (BPD) or death in extremely preterm infants. Further research with larger sample sizes is recommended to explore this potential BPD prevention strategy.
Area of Science:
- Neonatalogy
- Pediatric Pulmonology
- Endocrinology
Background:
- Bronchopulmonary dysplasia (BPD) is a significant complication in extremely preterm infants requiring mechanical ventilation.
- Hormonal factors, including oestradiol and progesterone, may play a role in lung development and injury prevention.
Purpose of the Study:
- To investigate the efficacy of postnatal oestradiol and progesterone replacement in preventing BPD or death in very preterm infants.
- To assess the safety and feasibility of continuous intravenous hormone infusion in this vulnerable population.
Main Methods:
- A randomized, placebo-controlled, double-blind study involving 83 infants with gestational age <29 weeks and birth weight <1000 g requiring mechanical ventilation.
- Infants received either oestradiol and progesterone (ESTRA-PRO) or a placebo via continuous intravenous lipid emulsion infusion for 2-4 weeks.
- The primary outcome was the incidence of BPD or death, analyzed using an intention-to-treat approach.
Main Results:
- The overall incidence of BPD or death was similar between the ESTRA-PRO group (44%) and the placebo group (48%), with no statistically significant difference (p = 0.38).
- In infants treated strictly according to protocol, the incidence of BPD was lower in the ESTRA-PRO group (14%) compared to the placebo group (32%), though this did not reach statistical significance (p = 0.08).
Conclusions:
- Postnatal replacement therapy with oestradiol and progesterone is not effective in preventing BPD or death in extremely preterm infants.
- Larger, more adequately powered clinical trials are necessary to definitively evaluate the potential role of this hormonal intervention in BPD prevention.
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).
Conclusion:
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.
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