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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HFOV weaning protocol 1

    Other intervention

    weaning preterm neonates with RDS from HFOV directly to CPAP

  • HFOV weaning protocol 2

    Other intervention

    weaning of preterm neonates with RDS to CMV then to CPAP

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Group 1 (intervention group)Experimental treatment 1 intervention
Group B: Group II (Control group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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