What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

May 13, 2026The Italian Journal of Pediatrics/Italian journal of pediatrics0 citationsOpen Access

Hemodynamic effects of high frequency oscillatory ventilation versus conventional mechanical ventilation in term neonates with persistent pulmonary hypertension: a single-center randomized trial

DADoaa El AmrousyTanta University HKHassan KouraTanta University NANoura AbdouTanta University

Key Points

To evaluate hemodynamics in full-term neonates with persistent pulmonary hypertension on different ventilation methods.
Single-center randomized trial including 64 full-term neonates with persistent pulmonary hypertension.
Participants were divided into two groups: high frequency oscillatory ventilation and conventional mechanical ventilation.
Heart rate, blood pressure, echocardiography, and cerebral ultrasound were measured at days 1, 3, and 7.
Heart rate, right ventricular diameter, and mean pulmonary artery diameter decreased significantly by day 7.
Systolic, diastolic, and mean blood pressures increased significantly in both groups by day 7.
Systolic pulmonary artery pressure and tricuspid pressure gradient decreased significantly by days 3 and 7.

Abstract

Abstract Background We aimed to evaluate the hemodynamics in full-term neonates with persistent pulmonary hypertension (PPH) on high frequency oscillatory ventilation (HFOV) versus conventional mechanical ventilation (CMV). Methods This trial was conducted on 64 full-term neonates with PPH who needed MV and were randomly divided into two groups: group I: 32 neonates with PPH on HFOV, and group II: 32 neonates with PPH on CMV. Two neonates weaned early from group I, and another two neonates died in group II; they were excluded from the study. Heart rate (HR), systolic, diastolic, and mean blood pressure (SBP, DBP, MBP) were recorded. Echocardiography was performed to measure right ventricular diameter (RVD), right atrial diameter (RAD), mean pulmonary artery diameter (MPA), left ventricular dimensions, LV systolic function, tricuspid pressure gradient (TR PG), systolic pulmonary artery pressure (SPAP), tricuspid annulus plane systolic excursion (TAPSE), superior vena cava (SVC) flow, right and left ventricular output (RVO, LVO). Cerebral ultrasound was done to measure the resistive index (RI) of middle cerebral artery (MCA) and to detect intraventricular hemorrhage (IVH). All measurements were performed at day 1, 3, and 7. Results HR, RVD, RAD, and MPA significantly decreased, but SBP, DBP, MBP, LVO, LV dimensions, and function significantly increased in both groups at day 7. SPAP and TR PG decreased significantly at day 3 and 7; however, TAPSE and RVO increased significantly at day 3 and 7 in both groups. LVO and RVO increased more significantly at day 7 in the CMV group. SVC flow didn’t differ significantly in both groups on follow-up. RI of MCA significantly decreased in the HFOV group only at day 7. Moreover, IVH was comparable in both groups. Conclusion HFOV and CMV have positive comparable effects on hemodynamics in full-term neonates with PPH. Clinical trial registration The study was registered at pan African clinical trial registry with registration number (PACTR202104624409011) with registration date 6th April 2021. Link for trial registration ( https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15789 ).

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