RecruitingPhase 1NCT06367881
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates
Sponsor
Ain Shams University
Enrollment
60 participants
Start Date
Aug 18, 2022
Study Type
INTERVENTIONAL
Summary
An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.
Eligibility
Min Age: 1 DayMax Age: 2 Days
Inclusion Criteria6
- Gestational age ≤ 35 weeks with
- Respiratory distress syndrome.
- Need surfactant administration based on European RDS consensus: (Sweet et al., 2019)
- If intubation is required as part of stabilization.
- Clinically presenting with increased work of breathing including (tachypnea, nasal flaring, grunting, retractions, and cyanosis, with decreased air entry on auscultation.
- Babies who are worsening when FiO2 >0.30 on CPAP pressure of at least 6 cm H2O to maintain normal saturations.
Exclusion Criteria7
- Preterm neonates with evidence of any of the following will be excluded:
- Chromosomal anomaly or Congenital heart defect
- Hemodynamically significant patent ductus arteriosus.
- Early-onset sepsis or bacterial infection
- Congenital pneumonia
- Intra ventricular hemorrhage (IVH)
- Parenteral refusal to participate.
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Interventions
DRUGAlveofact
Intratracheal High-dose Alveofact versus Low-dose Alveofact with or without Budesonide
DRUGBudesonide
Budesonide
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06367881