Minidex

Minidex: The efficacy and safety of very low dose dexamethasone used to facilitate the extubation of ventilator dependent preterm babies who are at high risk of bronchopulmonary dysplasia.

Trial started: 2015  Trial ended: 2018 

Summary

Objectives

To assess the efficacy and safety of very low-dose dexamethasone in facilitating the extubation of ventilator-dependent preterm babies born at <30 weeks' gestation who are at high risk of developing bronchopulmonary dysplasia (BPD).

Methods

A multicentre, randomised, masked, parallel-group, placebo-controlled Phase 2b feasibility trial conducted in 11 tertiary neonatal units in the UK. The trial was designed as a feasibility study for a subsequent trial of clinical effectiveness. Ventilator-dependent preterm babies born at <30 weeks' gestation, aged 10–21 days, receiving at least 30% inspired oxygen and at high risk of developing BPD were randomised to receive either very low-dose dexamethasone (50 µg/kg/day for 13 doses) or matched placebo.

Outcome measures

Primary outcome: Time to extubation. Secondary outcomes: Extubation by day 7 of the intervention; survival to 36 weeks' postmenstrual age (PMA) or discharge home; respiratory morbidity to 36 weeks' PMA or discharge home; cytokine profile; safety outcomes; and parent/family experience.

Results

The main metric of feasibility, namely recruitment, proved difficult. There was a tendency for open-label medication and a higher than predicted rate of suspected/confirmed sepsis among babies. Recruitment was halted after 22 babies had been enrolled. It was found that, compared with the placebo group, a higher proportion of babies were extubated at day 7 of life [5/8 (62.5%) in the very low-dose dexamethasone group vs. 2/6 (33.3%) in the placebo group] and duration of invasive ventilation was lower (a median of 23 days for the very low-dose dexamethasone group vs. a median of 31 days for the placebo group) in the very low-dose dexamethasone group. This is supported by a trend for an increased requirement for open-label rescue steroids in control group babies (41.7% in the very low-dose dexamethasone group vs. 80% in the placebo group). Given the limited sample size, only descriptive statistics can be given; firm conclusions cannot be drawn.

Conclusions

It is not feasible to conduct the required pragmatic trial of clinical effectiveness.

Adapted from: Yates H, Chiocchia V, Linsell L, et al. Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Efficacy and Mechanism Evaluation. 2019;6(8). https://doi.org/10.3310/eme06080. © Queen's Printer and Controller of HMSO 2019. Adapted for presentation on this website.