Background Respiratory care practice to avoid intubation includes nCPAP or NIPPV.
Aims To compare rates of BPD or death, in ELBW infants randomised to NIPPV or CPAP.
Methods Eligibility criteria: gestation <30 weeks and birth weight (BW) <1000 g; requiring non-invasive support in first 7 days of life, or post-extubation within first 28 days.
Manoeuvre ELBW were randomised (stratified by centre, BW, and prior intubation) to either NIPPV (synchronised or not) or nCPAP. Guidelines for extubation and re-intubation were provided.
Primary outcome Composite of death by 36 weeks postmenstrual age, or BPD [defined as receiving ventilation; or on >30% supplemental O2 at 36 weeks, or a positive oxygen reduction test (ORT-BPD) if in 22%-29% O2]. Sample Size and Analysis: 500 patients per group giving 80% power for a 20% relative risk reduction in the primary outcome (0.05, 2 tailed).
Results Preliminary Results: 36 sites randomised 1009 infants. Primary outcome is unknown for 25 [2 parents withdrew consent, 21 did not receive an ORT (due to early transfer) and 2 are currently incomplete]. Data for n=984 (487 NIPPV, 497 nCPAP) babies are presented; as well as supporting analysis for n=1005. Key baseline characteristics were equally balanced between treatment groups [mean (SD) BW 801 g (131) vs 805 g (126); 92% vs 91% received antenatal corticosteroids]. Observed rates of BPD or death were similar between the two treatments.
When we used the old definition for BPD (any supplemental O2 at 36 weeks) for 21 infants (who did not receive an ORT) the results were unchanged. No differences were seen comparing early or later use of NIPPV. There were no differences in outcomes whether NIPPV was synchronised or not. Rates of necrotising enterocolitis and nasal excoriation were similar.
Conclusions We conclude that for ELBW infants who require non-invasive respiratory support, current devices for NIPPV do not confer additional benefit or risk, when compared to nCPAP for survival to 36 weeks without BPD.