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

ConditionRespiratory Distress Syndrome (Neonatal)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorMansoura University Children Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Severe hypercapnea PaCO2 > 60 mmHg associated with pH < 7.25.

Hypoxemia PaO2 < 50 mmHg, with FiO2 > 40%.

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.

Disqualifiers

Major congenital malformations or chromosomal aberrations.

Inborn errors of metabolism.

Severe intraventricular hemorrhage (IVH) grade III or IV

Trial design

Treatments tested in this trial

HFOV weaning protocol 1
HFOV weaning protocol 2

Treatment groups

110 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Mansoura University Children Hospital

Lead sponsor

Source ClinicalTrials.gov