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

Mansoura University Children Hospital

Status: Enrolling

Conditions: Respiratory Distress Syndrome (Neonatal)

Treatments: Other: HFOV weaning protocol 2; Other: HFOV weaning protocol 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07202299

MD.25.05.1000

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Group 1 (intervention group)

Experimental group

Description:

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

Treatment:

Other: HFOV weaning protocol 1

Group II (Control group)

Active Comparator group

Description:

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) .

Treatment:

Other: HFOV weaning protocol 2