Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2027-09-30

Brief Summary

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Our study is a randomized controlled trial that compares two weaning protocols of preterm infants with respiratory distress syndrome who are ventilated on high frequency oscillatory ventilation in order to establish the best weaning strategy with the least complications possible for this group of patients.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome (Neonatal)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (intervention group)

Group I (Intervention group): Fifty five preterm infants with direct weaning from HFOV (high frequency oscillatory ventilation) to CPAP (continuous positive airway pressure).

Group Type EXPERIMENTAL

HFOV weaning protocol 1

Intervention Type OTHER

weaning preterm neonates with RDS from HFOV directly to CPAP

Group II (Control group)

Group II (Control group): Fifty five preterm infants with weaning from HFOV (high frequency oscillatory ventilation) to conventional mechanical ventilation (CMV) then to CPAP (continuous positive airway pressure) .

Group Type ACTIVE_COMPARATOR

HFOV weaning protocol 2

Intervention Type OTHER

weaning of preterm neonates with RDS to CMV then to CPAP

Interventions

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HFOV weaning protocol 1

weaning preterm neonates with RDS from HFOV directly to CPAP

Intervention Type OTHER

HFOV weaning protocol 2

weaning of preterm neonates with RDS to CMV then to CPAP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm infants with RDS whose gestational age is 34 weeks or less who required HFOV for more than 24 hours duration due to failure of non- invasive respiratory support due to any of the following:

1. Severe hypercapnea PaCO2 \> 60 mmHg associated with pH \< 7.25.
2. Hypoxemia PaO2 \< 50 mmHg, with FiO2 \> 40%.
3. Frequent apneas: 6 or more episodes of apnea requiring mild or moderate stimulation within 6-hour period or one apneic episode requiring bag and mask positive pressure ventilation.

Exclusion Criteria

Preterm infants with any of the following :

1. Major congenital malformations or chromosomal aberrations.
2. Inborn errors of metabolism.
3. Severe intraventricular hemorrhage (IVH) grade III or IV

Eligible Sex

ALL

Accepts Healthy Volunteers

No