Preterm Birth Clinical Trial
Official title:
Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates
An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
| Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
| Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
| Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
| Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
| Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
| Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
| Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
| Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
| Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
| Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
| Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
| Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
| Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
| Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
| Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
| Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
| Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|