Pressure Regulated Volume Control Ventilation in Neonates Persistent Pulmonary Hypertension

NCT07850908 · tracked via the Priya Life Science Egypt tracker

Sponsor

Tanta University

Phase

Not applicable

Started

2026-02-28

Last updated

2026-09-30

Condition(s) studied

Persistent Pulmonary HypertensionMechanical Ventilation StrategiesNeonatal Intensive Care Unit (NICU)Ventilation

Investigational drug(s) / intervention(s)

Pressure-Controlled VentilationGroup II (Pressure-Regulated Volume Control)

Pressure-Controlled Ventilation: Group I (Pressure-Controlled Ventilation) will be ventilated using Pressure-Controlled Ventilation mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters.

Group II (Pressure-Regulated Volume Control): Group II (PRVC) will be ventilated using Pressure-Regulated Volume Control (PRVC) mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures.

Study summary

This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.

Eligibility

Sex

ALL

Min age

1 Day

Max age

2 Months

Healthy volunteers

Inclusion Criteria: Neonates with confirmed diagnosis of persistent pulmonary hypertension of the newborn (echocardiographic evidence of elevated pulmonary artery pressures) who needed Mechanical ventilation . * Gestational age ≥ 34 weeks. * Requiring mechanical ventilation within the first week of life. Exclusion Criteria: * Neonates with major congenital heart disease (except patent ductus arteriosus or patent foramen ovale). * Severe congenital anomalies (e.g., diaphragmatic hernia, chromosomal abnormalities). * Prior use of high-frequency oscillatory ventilation before enrollment. * Parental refusal to participate.

Primary outcome measure(s)

Improvement of oxygenation index. — at day 5 of ventilation
The oxygenation index was calculated on each intubated patient for days 1, 3 and 7 using the following formula: mean airway pressure × FIO2/PaO2.

Trial sites (1)

Facility	City	Region	Status
Tanta University	Tanta	Gharbia Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07850908 on ClinicalTrials.gov ↗ ← All trials in Egypt