NCT00000567

Brief Summary

To compare the efficacy and safety of high frequency ventilation (HFV) with that of standard, mechanical ventilation in premature infants of less than 2000 grams.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1984

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 14, 2016

Status Verified

December 1, 2005

First QC Date

October 27, 1999

Last Update Submit

April 13, 2016

Conditions

Bronchopulmonary DysplasiaLung DiseasesRespiratory Distress Syndrome

Interventions

high-frequency ventilationPROCEDURE

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Boy and girl infants weighing less than 2000 g. who required mechanical ventilation within 24 hours of birth and had been treated for less than 12 hours with conventional mechanical ventilation before randomization.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • HIFI Study Group. High-frequency oscillatory ventilation compared with conventional mechanical ventilation in the treatment of respiratory failure in preterm infants. N Engl J Med. 1989 Jan 12;320(2):88-93. doi: 10.1056/NEJM198901123200204.

    PMID: 2643039BACKGROUND

  • High-frequency oscillatory ventilation compared with conventional mechanical ventilation in the treatment of respiratory failure in preterm infants: assessment of pulmonary function at 9 months of corrected age. HiFi Study Group. J Pediatr. 1990 Jun;116(6):933-41. doi: 10.1016/s0022-3476(05)80657-2.

    PMID: 2112188BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary DysplasiaLung DiseasesRespiratory Distress Syndrome

Interventions

High-Frequency Ventilation

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Kenneth Poole

    RTI International

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1984

Last Updated

April 14, 2016

Record last verified: 2005-12