Clinical trial NCT06367881: Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
Official title: Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neonatal Respiratory Distress Syndrome
Inflammatory Response
Premature Lungs
Neutrophil Extracellular Trap Formation
Preterm Birth
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Assessment of Neutrophil Extracellular Trap (NET)
timeFrame: 48 hours after treatment
Secondary outcomes:
measure: comparison of Alveolar with whole blood NET formation
timeFrame: 48 hours
measure: Clinical out come
timeFrame: 1 month
measure: Assessment of Reactive Oxygen Species (ROS)
timeFrame: 48 hours
measure: oxygen needs
timeFrame: 1 month
measure: Hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517
Study officials:
References: