Trial Outcomes & Findings for HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level (NCT NCT05682937)

Last Updated: 2025-02-21

Results Overview

ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.

Recruitment status

TERMINATED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

before sigh (baseline) and after sigh (2 hours)

Results posted on

2025-02-21

Participant Flow

Ninety-four infants were assessed for eligibility; 64 were excluded because of previous or current pulmonary air leaks (n = 3), heterogeneous lung diseases (n = 7), suspected or confirmed grade III-IV intraventricular hemorrhage (n = 1), hemodynamic instability despite using an inotrope (n = 15), PaCO2 level \< 45 or \> 70 mm Hg before intervention (n = 30), moribund status (n = 7), and parents' decision not to participate (n = 1). Thirty participants were finally enrolled.

Participant milestones

Participant milestones
Measure	HFOV-sigh Mode HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HFOV-sigh Mode n=30 Participants HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Age, Continuous	1.88 day n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gestational age	33.6 weeks STANDARD_DEVIATION 4.1 • n=5 Participants
Birth weight	2305 grams STANDARD_DEVIATION 853 • n=5 Participants

PRIMARY outcome

Timeframe: before sigh (baseline) and after sigh (2 hours)

ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.

Outcome measures

Outcome measures
Measure	HFOV-sigh Mode n=30 Participants HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Arterial pCO2 Level HFOV before sigh	48.8 mm Hg Standard Deviation 3.1
Arterial pCO2 Level HFOV after sigh	45.2 mm Hg Standard Deviation 6.6

SECONDARY outcome

Timeframe: before sigh (baseline) and after sigh (2 hours)

Population: oxygen index = mean airway pressure x FiO2 / PaO2

oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.

Outcome measures

Outcome measures
Measure	HFOV-sigh Mode n=30 Participants HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Oxygenation HFOV after sigh	2.95 no unit Interval 2.37 to 3.83
Oxygenation HFOV before sigh	3.06 no unit Interval 2.48 to 4.26

SECONDARY outcome

Timeframe: 2 hours after sigh breaths

Population: the frequency of each MAP level was presented by the count of participants

Mean Airway Pressure (MAP), cmH2O

Outcome measures

Outcome measures
Measure	HFOV-sigh Mode n=30 Participants HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Mean Airway Pressure MAP = 7 cmH2O	5 Participants
Mean Airway Pressure MAP = 8 cmH2O	12 Participants
Mean Airway Pressure MAP = 9 cmH2O	8 Participants
Mean Airway Pressure MAP = 10 cmH2O	4 Participants
Mean Airway Pressure MAP = 13 cmH2O	1 Participants

Adverse Events

HFOV-sigh Mode

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

Anucha Thatrimontrichai

Prince of Songkla University

Phone: 66 74451257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place