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Objective. In uncontrolled clinical trials, negative extrathoracic pressure has been shown to be an effective respiratory support. We aimed to assess its role in the context of current neonatal intensive care.

Design. A randomized controlled trial, with sequential analysis of matched pairs of infants. Matching was undertaken by stratified randomization from 15 groups divided according to gestational age, oxygen requirement, and whether patients were intubated at 4 hours of age.

Setting. Two neonatal intensive care units.

Patients. Two hundred forty-four patients (birth weight 1.53 ± 0.69 kg (mean ± SD); gestational age 30.4 ± 3.5 weeks) with respiratory failure.

Interventions. Patients were randomized at 4 hours of age to receive either standard neonatal intensive care, or standard care plus continuous negative extrathoracic pressure (CNEP, -4 to -6 cmH₂O) applied within a purpose-designed neonatal incubator …