Respiratory Distress Syndrome (Neonatal)
Conditions
Brief summary
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.
Interventions
OTHERHFOV weaning protocol 1
weaning preterm neonates with RDS from HFOV directly to CPAP
OTHERHFOV weaning protocol 2
weaning of preterm neonates with RDS to CMV then to CPAP
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparing weaning failure rate between 2 groups | 72 hours after weaning | 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). |
Countries
Egypt
Contacts
Primary ContactYasmina E Keshta
Outcome results
None listed