Evaluating the effects of Alveofact with or without steroids in premature infants with respiratory distress

Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates

This study is testing if giving different doses of a treatment called Alveofact, with or without a steroid, can help premature babies with breathing problems do better and have fewer lung injuries.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 1 Day to 2 Days
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06367881 on ClinicalTrials.gov

What this trial studies

This exploratory randomized double-arm controlled trial aims to assess the immunomodulatory effects of low versus high doses of Alveofact, with or without Budesonide, in treating neonatal respiratory distress syndrome (RDS) in preterm infants. The study focuses on understanding how these treatments can reduce lung injury and improve survival rates by evaluating their impact on inflammatory responses and neutrophil extracellular trap formation. Eligible participants include preterm infants with RDS who require surfactant therapy, and the study will monitor various clinical outcomes related to respiratory function and inflammation.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at or before 35 weeks of gestation who are experiencing respiratory distress syndrome and require surfactant administration.

Not a fit: Patients with significant congenital anomalies, infections, or other severe health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for neonatal respiratory distress syndrome, potentially enhancing survival rates and reducing complications in preterm infants.

How similar studies have performed: While the combination of surfactant therapy and steroids has shown promise in previous studies, this specific approach is still exploratory and may provide novel insights into treatment for neonatal RDS.

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.

Where this trial is running

Cairo

• Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517 — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Amira Mostafa Rashad Ibrahim

Conditions Neonatal Respiratory Distress Syndrome; Inflammatory Response; Premature Lungs; Neutrophil Extracellular Trap Formation; Preterm Birth