HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Not Applicable

Terminated

Brief Summary: The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation.

The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).

Detailed Description: Sample size calculation (before and after intervention: two dependent mean)

* alpha = 0.05, beta = 0.2,

* Delta = 1.9, SD. = 4.35

* Calculated sample size = 42

* increase sample size if loss follow up 20%

* Final sample size (n) = 50

Subgroup analysis for

* preterm neonates

* very preterm or very low birth weight neonates

* extremely preterm or extremely low birth weight neonates

Recruitment & Eligibility

Inclusion Criteria

Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days
Already ventilated with high frequency ventilation at least 1 hours
An umbilical or peripheral arterial catheterization was available

Exclusion Criteria

Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium)
Heterogeneous lung disease including MAS, congenital diaphragmatic hernia
Suspected lung hypoplasia
Suspected or confirmed intraventricular hemorrhage grade III-IV
Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3
Hemodynamic instability despite using inotrope(s)
Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention
Need a new arterial puncture for samples both before and after interventions
Moribund status
Parents' decision not to participate

Arm && Interventions

Group	Intervention	Description
HFOV-sigh mode	HFOV-sigh	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. No change in Hz, MAP, delta pressure, and increased FiO2 less than 0.1 occurred between intervention.

Primary Outcome Measures

Name	Time	Method
Arterial pCO2 Level	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.

Secondary Outcome Measures

Name	Time	Method
Oxygenation	before sigh (baseline) and after sigh (2 hours)	oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.
Mean Airway Pressure	2 hours after sigh breaths	Mean Airway Pressure (MAP), cmH2O