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The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome.
Pediatrics. 1996 Dec; 98(6 Pt 1):1044-57.Ped

Abstract

OBJECTIVE

To compare the hospital course and clinical outcome of preterm infants with respiratory distress syndrome treated with surfactant and managed with high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CV) as their primary mode of ventilator support.

DESIGN

A prospective randomized clinical trial.

SETTING

Three community-based level III neonatal intensive care units.

SUBJECTS

A total of 125 neonates who were 35 weeks or less estimated gestation requiring intubation and assisted ventilation for respiratory distress syndrome with arterial to alveolar oxygen ratio less than .50.

INTERVENTIONS

Patients were randomized to continue CV (61 patients) or be changed to HFOV (64 patients) after exogenous surfactant administration (100 mg/kg). HFOV was used in a strategy to promote lung recruitment and maintain lung volume. Protocol respiratory care guidelines were followed; otherwise routine care was provided by each neonatal intensive care unit.

MEASUREMENTS AND MAIN RESULTS

No differences were noted in demographic features between the two study groups. The study population birth weight was 1.51 +/- .47 kg (mean +/- SD), gestational age was 30.9 +/- 2.5 weeks, and study entry age was 2 to 3 hours. Patients randomized to HFOV demonstrated the following significant findings compared with CV-treated patients: vasopressor support was less intensive; surfactant redosing was not as frequent; oxygenation improved more rapidly and remained higher during the first 7 days; fewer infants required prolonged supplemental oxygen or ventilator support; treatment failure was reduced; more patients survived without chronic lung disease at 30 days; need for continuous supplemental oxygen at discharge was less; frequency of necrotizing enterocolitis illness was lower; there were fewer abnormal hearing tests; and hospital costs were decreased. No differences were seen between the two study groups in the frequency or severity of patent ductus arteriosus, air leak, retinopathy of prematurity, or intraventricular hemorrhage. Length of hospital stay and survival to discharge were similar for HFOV- and CV-treated infants.

CONCLUSIONS

When used early with a lung recruitment strategy, HFOV after surfactant replacement resulted in clinical outcomes consistent with a reduction in both acute and chronic lung injury. Benefit was evident for preterm infants both less than or equal to 1 kg and more than 1 kg. In addition, early HFOV treatment may have had a more global effect on patient health throughout the hospitalization, resulting in reduced morbidity and decreased health care cost.

Authors+Show Affiliations

Utah Valley Regional Medical Center, Provo 84604, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8951252

Citation

Gerstmann, D R., et al. "The Provo Multicenter Early High-frequency Oscillatory Ventilation Trial: Improved Pulmonary and Clinical Outcome in Respiratory Distress Syndrome." Pediatrics, vol. 98, no. 6 Pt 1, 1996, pp. 1044-57.
Gerstmann DR, Minton SD, Stoddard RA, et al. The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome. Pediatrics. 1996;98(6 Pt 1):1044-57.
Gerstmann, D. R., Minton, S. D., Stoddard, R. A., Meredith, K. S., Monaco, F., Bertrand, J. M., Battisti, O., Langhendries, J. P., Francois, A., & Clark, R. H. (1996). The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome. Pediatrics, 98(6 Pt 1), 1044-57.
Gerstmann DR, et al. The Provo Multicenter Early High-frequency Oscillatory Ventilation Trial: Improved Pulmonary and Clinical Outcome in Respiratory Distress Syndrome. Pediatrics. 1996;98(6 Pt 1):1044-57. PubMed PMID: 8951252.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome. AU - Gerstmann,D R, AU - Minton,S D, AU - Stoddard,R A, AU - Meredith,K S, AU - Monaco,F, AU - Bertrand,J M, AU - Battisti,O, AU - Langhendries,J P, AU - Francois,A, AU - Clark,R H, PY - 1996/12/1/pubmed PY - 1996/12/1/medline PY - 1996/12/1/entrez SP - 1044 EP - 57 JF - Pediatrics JO - Pediatrics VL - 98 IS - 6 Pt 1 N2 - OBJECTIVE: To compare the hospital course and clinical outcome of preterm infants with respiratory distress syndrome treated with surfactant and managed with high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CV) as their primary mode of ventilator support. DESIGN: A prospective randomized clinical trial. SETTING: Three community-based level III neonatal intensive care units. SUBJECTS: A total of 125 neonates who were 35 weeks or less estimated gestation requiring intubation and assisted ventilation for respiratory distress syndrome with arterial to alveolar oxygen ratio less than .50. INTERVENTIONS: Patients were randomized to continue CV (61 patients) or be changed to HFOV (64 patients) after exogenous surfactant administration (100 mg/kg). HFOV was used in a strategy to promote lung recruitment and maintain lung volume. Protocol respiratory care guidelines were followed; otherwise routine care was provided by each neonatal intensive care unit. MEASUREMENTS AND MAIN RESULTS: No differences were noted in demographic features between the two study groups. The study population birth weight was 1.51 +/- .47 kg (mean +/- SD), gestational age was 30.9 +/- 2.5 weeks, and study entry age was 2 to 3 hours. Patients randomized to HFOV demonstrated the following significant findings compared with CV-treated patients: vasopressor support was less intensive; surfactant redosing was not as frequent; oxygenation improved more rapidly and remained higher during the first 7 days; fewer infants required prolonged supplemental oxygen or ventilator support; treatment failure was reduced; more patients survived without chronic lung disease at 30 days; need for continuous supplemental oxygen at discharge was less; frequency of necrotizing enterocolitis illness was lower; there were fewer abnormal hearing tests; and hospital costs were decreased. No differences were seen between the two study groups in the frequency or severity of patent ductus arteriosus, air leak, retinopathy of prematurity, or intraventricular hemorrhage. Length of hospital stay and survival to discharge were similar for HFOV- and CV-treated infants. CONCLUSIONS: When used early with a lung recruitment strategy, HFOV after surfactant replacement resulted in clinical outcomes consistent with a reduction in both acute and chronic lung injury. Benefit was evident for preterm infants both less than or equal to 1 kg and more than 1 kg. In addition, early HFOV treatment may have had a more global effect on patient health throughout the hospitalization, resulting in reduced morbidity and decreased health care cost. SN - 0031-4005 UR - https://www.unboundmedicine.com/medline/citation/8951252/The_Provo_multicenter_early_high_frequency_oscillatory_ventilation_trial:_improved_pulmonary_and_clinical_outcome_in_respiratory_distress_syndrome_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=8951252 DB - PRIME DP - Unbound Medicine ER -