Phase 1 N=14 Treatment

Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Infant Respiratory Distress Syndrome · Respiratory Insufficiency · Apnea of Prematurity

Bottom Line

View on ClinicalTrials.gov: NCT00296231 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2010

Primary outcome: Primary: pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values — 50; 45 mm Hg — p=0.011

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Nasal high frequency ventilation (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Tarah T Colaizy
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values	50; 45	0.011 sig
SECONDARY Transcutaneous CO2 Measurements as a Trend Throughout Intervention	47; 46	—

Summary

The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.

Eligibility Criteria

Inclusion Criteria

birthweight less than 1500 g
Age >7 days
Free of severe intraventricular hemorrhage (Grade III-IV)
requiring nasal continuous positive airway pressure with a stable compensated respiratory acidosis (pH 7.25 - 7.45, pCO2 > 43 mm Hg),
medically stable.

Exclusion Criteria

major congenital anomalies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00296231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.