UnknownPhase 1

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

Egypt60 participantsStarted 2022-08-18

Plain-language summary

An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.

Who can participate

Age range1 Day – 2 Days

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Assessment of Neutrophil Extracellular Trap (NET)

Timeframe: 48 hours after treatment

Trial details

NCT IDNCT06367881

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07

Contact for this trial

Amira Mostafa Rashad Ibrahim

01095420315 Amira.Mostafa@med.asu.edu.eg

View on ClinicalTrials.gov More Neonatal Respiratory Distress Syndrome trials