Minimal ventilation to prevent bronchopulmonary dysplasia in extremely-low-birth-weight infants☆,☆☆,★
Section snippets
Study subjects
Patients were recruited between February 1998 and September 1998 at 13 clinical centers of the NICHD Neonatal Research Network (see Appendix). The institutional review board at each center approved the protocol, and informed consent was obtained for each infant. Infants weighing 501 g to 1000 g who were intubated, receiving mechanical ventilation before 12 hours of age, and had an indwelling vascular catheter were eligible for the study. Infants weighing 751 g to 1000 g also were required to
Results
The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants.21
Discussion
Although the strategy of minimal ventilation did not significantly decrease death or BPD, the hypothesized treatment effect size is included within the 95% CI of the primary outcome results, suggesting that the lack of findings may be due to the limited sample size of this terminated trial. Although not the primary outcome of this trial, the observation that ventilator support at 36 weeks was reduced suggests a need for further study of minimal ventilation in infants at high risk for BPD.
Acknowledgements
We thank Gordon Avery, MD, Mary D'Alton, MD, John Fletcher, PhD, Christine Gleason, MD, Maureen Maguire, PhD, and Carol Redmond, PhD, for their contributions as members of the Data Safety and Monitoring Committee and to our medical and nursing colleagues and the infants and their parents for participation in the study.
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Supported by cooperative agreements with the National Institute of Child Health and Human Development (U10 HD34216; U10 HD34167; U10 HD21373; U10 HD27881; U10 HD21385; U10 HD27853; U10 HD27904; U10 HD21397; U01 HD36790; U10 HD27851; U10 HD21364; U10 HD27871; U10 HD21415; U10 HD27880) and by General Clinical Research Centers grants (M01 RR02635; M01 RR02172; M01 RR00997; M01 RR08084; M01 RR06022; M01 RR08084; M01 RR00070).
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*Avroy A. Fanaroff, MB, BCh (Case Western Reserve University), Richard A. Ehrenkranz, MD (Yale University), Sheldon B. Korones, MD (University of Tennessee at Memphis), and David K. Stevenson, MD (Stanford University).
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Reprint requests: Waldemar A. Carlo, MD, University of Alabama at Birmingham, Division of Neonatology, 525 New Hillman Building, 619 South 19th St, Birmingham, AL 35233-7335.