Pressure Regulated Volume Control Ventilation in Neonates Persistent Pulmonary Hypertension

NCT07850908 | Enrolling By Invitation

• 1 other identifier: 36264MS10101051/ 1/26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Pulmonary Hypertension; Mechanical Ventilation Strategies; Neonatal Intensive Care Unit (NICU); Ventilation

Keywords

Neonatal Intensive Care Unit; Pressure-Regulated Volume Control; ventilation; Mechanical ventilation strategies

Outcome Measures

Primary Outcomes (1)

• Improvement of oxygenation index.

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

  at day 5 of ventilation

Secondary Outcomes (1)

• Change in Mean Airway Pressure

  At 6, 12, 24, and 48 hours after initiation of ventilation

Study Arms (2)

Group I (pressure-controlled ventilation)

EXPERIMENTAL

Group I (pressure-controlled ventilation) will be ventilated using Pressure-Controlled Ventilation (PCV) 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.

Device: Pressure-Controlled Ventilation

Group II (Pressure-Regulated Volume Control )

EXPERIMENTAL

Group II (Pressure-Regulated Volume Control ) will be ventilated using Pressure-Regulated Volume Control 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.

Device: Group II (Pressure-Regulated Volume Control)

Interventions

Pressure-Controlled Ventilation DEVICE

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 I (pressure-controlled ventilation)

Group II (Pressure-Regulated Volume Control) DEVICE

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.

Group II (Pressure-Regulated Volume Control )

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Pediatrics

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 30, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)