Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

Launched by AIN SHAMS UNIVERSITY · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different doses of a medication called Alveofact, with or without a steroid called Budesonide, can help babies with a condition known as Neonatal Respiratory Distress Syndrome (RDS). RDS is a common problem in premature infants, where their lungs are not fully developed, making it hard for them to breathe. The trial aims to find out whether using a lower or higher dose of Alveofact can improve the immune response in these babies and help them breathe better.

To participate in the trial, babies need to be born before 35 weeks of pregnancy and show signs of RDS, such as difficulty breathing and requiring extra oxygen support. Unfortunately, babies with certain health issues, like heart defects or infections, cannot join the study. If eligible, caregivers can expect their child to receive either low or high doses of Alveofact, and they will be monitored to see how well they respond to the treatment. This study is currently looking for participants, and it is an important step in finding better treatments for premature infants struggling with breathing problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age ≤ 35 weeks with
• • 1. Respiratory distress syndrome.
• • 2. Need surfactant administration based on European RDS consensus: (Sweet et al., 2019)
• • 3. If intubation is required as part of stabilization.
• • 4. Clinically presenting with increased work of breathing including (tachypnea, nasal flaring, grunting, retractions, and cyanosis, with decreased air entry on auscultation.
• • 5. Babies who are worsening when FiO2 \>0.30 on CPAP pressure of at least 6 cm H2O to maintain normal saturations.
• Exclusion Criteria:
• Preterm neonates with evidence of any of the following will be excluded:
• • 1. Chromosomal anomaly or Congenital heart defect
• • 2. Hemodynamically significant patent ductus arteriosus.
• • 3. Early-onset sepsis or bacterial infection
• • 4. Congenital pneumonia
• • 5. Intra ventricular hemorrhage (IVH)
• • 6. Parenteral refusal to participate.