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

Last updated: April 15, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

1

Condition

Miscarriage

Respiratory Failure

Lung Injury

Treatment

Alveofact

Budesonide

Clinical Study ID

NCT06367881
MD 185/ 2022
  • Ages 1-2
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestational age ≤ 35 weeks with
  1. Respiratory distress syndrome.
  2. Need surfactant administration based on European RDS consensus: (Sweet et al.,
  1. If intubation is required as part of stabilization.
  2. Clinically presenting with increased work of breathing including (tachypnea,nasal flaring, grunting, retractions, and cyanosis, with decreased air entry onauscultation.
  3. Babies who are worsening when FiO2 >0.30 on CPAP pressure of at least 6 cm H2O tomaintain normal saturations.

Exclusion

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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Alveofact
Phase: 1
Study Start date:
August 18, 2022
Estimated Completion Date:
October 31, 2024

Study Description

Neonatal respiratory distress syndrome (RDS) is caused by lung immaturity and surfactant deficiency in preterm newborns and is an important cause of morbidity and mortality.

Surfactant therapy plays an essential role in the management of RDS as it reduces lung injury and improves survival, While surfactant alone is very effective, some studies showed that its combination with budesonide significantly reduces BPD and inflammatory markers.

Neutrophils extracellular traps (NETs) are a defense mechanism where neutrophils are the reaction to microbial infection and cast a net-like structure. NETs are composed of chromatin decondensed and some 30 enzymes and peptides. Many components such as Neutrophil elastase (NE) and Myeloperoxidase enzyme (MPO) have antimicrobial, but also a cytotoxic property that causes tissue injury. The immune regulatory abilities of the pulmonary surfactant are known to alter the function of the adaptive and innate immune cells.

So, in this study, The Investigator will Assess the immunomodulatory effect of low and high doses of Alveofact with or without Budesonide.

Connect with a study center

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

    Cairo,
    Egypt

    Active - Recruiting

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