MedTrace Logo

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

NCT06367881 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-16

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

Alveofact

Intratracheal High-dose Alveofact versus Low-dose Alveofact with or without Budesonide

DRUG

Budesonide

Budesonide

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2024-07-31
Completion
2024-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06367881 on ClinicalTrials.gov