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Late outcomes of a randomized trial of high-frequency oscillation in neonates
Sanja Zivanovic1, Janet Peacock1, Mireia Alcazar-Paris1
1Author affiliations: Division of Asthma, Allergy and Lung Biology, Medical Research Council Centre for Allergic Mechanisms in Asthma (S.Z., M.A.-P., A.L., A.G.), and the Division of Health and Social Care Research (J.P., J.W.L.), King's College London, the National Institute for Health Research Biomedical Research Centre at Guy's and St. Thomas' National Health Service Foundation Trust and King's College London (S.Z., J.P., J.W.L., A.L., A.G.), the Institute for Women's Health, University College London (N.M.), and the Department of Child Health, St. George's, University of London (S.C.) - all in London.
Insights
High-frequency oscillatory ventilation (HFOV) improved small-airway function in adolescents born extremely prematurely. This randomized trial found superior lung function with HFOV compared to conventional ventilation, with no adverse functional outcomes.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Respiratory Physiology
Background:
- Observational studies suggested high-frequency oscillatory ventilation (HFOV) may improve small-airway function in neonates compared to conventional ventilation.
- Randomized trial data were needed to confirm these findings in long-term outcomes.
Purpose of the Study:
- To compare long-term lung function and respiratory health in adolescents born extremely prematurely.
- To assess the impact of HFOV versus conventional ventilation initiated in neonatal intensive care.
Main Methods:
- A multicenter randomized trial compared HFOV with conventional ventilation in 797 neonates born before 29 weeks gestation.
- Follow-up data were collected from 319 surviving adolescents (11-14 years old) on lung function and functional status.
- Primary outcome was forced expiratory flow at 75% of vital capacity (FEF75).
Main Results:
- Adolescents randomized to HFOV showed superior small-airway function (FEF75 z score: -0.97 vs. -1.19).
- Significant improvements favoring HFOV were observed in multiple respiratory measures, including FEV1, FVC, and diffusing capacity.
- HFOV group showed better teacher ratings in 3 of 8 school subjects; no other functional outcome differences were noted.
Conclusions:
- HFOV, compared to conventional ventilation, resulted in superior lung function in adolescents born extremely prematurely.
- No evidence of poorer functional outcomes was found in the HFOV group at 11-14 years of age.
Background:
Results from an observational study involving neonates suggested that high-frequency oscillatory ventilation (HFOV), as compared with conventional ventilation, was associated with superior small-airway function at follow-up. Data from randomized trials are needed to confirm this finding.
Methods:
We studied 319 adolescents who had been born before 29 weeks of gestation and had been enrolled in a multicenter, randomized trial that compared HFOV with conventional ventilation immediately after birth. The trial involved 797 neonates, of whom 592 survived to hospital discharge. We compared follow-up data from adolescents who had been randomly assigned to HFOV with follow-up data from those who had been randomly assigned to conventional ventilation, with respect to lung function and respiratory health, health-related quality of life, and functional status, as assessed with the use of questionnaires completed when the participants were 11 to 14 years of age. The primary outcome was forced expiratory flow at 75% of the expired vital capacity (FEF75).
Results:
The HFOV group had superior results on a test of small-airway function (z score for FEF75, -0.97 with HFOV vs. -1.19 with conventional therapy; adjusted difference, 0.23 [95% confidence interval, 0.02 to 0.45]). There were significant differences in favor of HFOV in several other measures of respiratory function, including forced expiratory volume in 1 second, forced vital capacity, peak expiratory flow, diffusing capacity, and impulse-oscillometric findings. As compared with the conventional-therapy group, the HFOV group had significantly higher ratings from teachers in three of eight school subjects assessed, but there were no other significant differences in functional outcomes.
Conclusions:
In a randomized trial involving children who had been born extremely prematurely, those who had undergone HFOV, as compared with those who had received conventional ventilation, had superior lung function at 11 to 14 years of age, with no evidence of poorer functional outcomes. (Funded by the National Institute for Health Research Health Technology Assessment Programme and others.).
