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

N/ARecruitingNCT07202299

Mansoura University Children Hospital110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Respiratory Distress Syndrome (Neonatal)

Interventions

HFOV weaning protocol 1OTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

comparing weaning failure rate between 2 groups

Failure of weaning will be considered if the infant develops respiratory distress again requiring re-intubation within 72 hours after extubation due to any of the following: 1. Severe hypercapnia (PaCO2 \> 60 mmHg) . 2. Hypoxemia ( PaO2 \< 50 mm Hg). 3. Frequent apnea (6 apnea episodes within 6-hour period or 1 apneic episode requiring bag and mask positive pressure ventilation). Or escalation of respiratory support as following: 4. Titration of CPAP level out of the assigned range (CPAP pressure \> 8 cmH2O). 5. Escalation to an alternate mode of non-invasive respiratoy support such as non-invasive positive pressure ventilation (NIPPV).

Time frame: 72 hours after weaning