Trial Outcomes & Findings for Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study (NCT NCT00296231)

Results Overview

Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

2 hours

Results posted on

2018-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Nassal High Frequency Ventilation Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nassal High Frequency Ventilation n=14 Participants Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 days n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.

Outcome measures

Outcome measures
Measure	Nassal High Frequency Ventilation n=14 Participants Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values pre-nasal high frequency ventilation pCO2	50 mm Hg Standard Deviation 6
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values post-nasal high frequency ventilation pCO2	45 mm Hg Standard Deviation 9

SECONDARY outcome

Timeframe: 2 hours

We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety

Outcome measures

Outcome measures
Measure	Nassal High Frequency Ventilation n=14 Participants Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
Transcutaneous CO2 Measurements as a Trend Throughout Intervention pre-nasal high frequency TCOM	47 torr Standard Deviation 5
Transcutaneous CO2 Measurements as a Trend Throughout Intervention post-nasal high frequency ventilation TCOM	46 torr Standard Deviation 5

Adverse Events

Nassal High Frequency Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tarah Colaizy

University of Iowa

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place