Necrotizing Enterocolitis Clinical Trial
Official title:
Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be
of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To
date, there is no specific therapy for NEC that has been found to improve outcome, but
corticosteroids have yet to be investigated in that capacity. Therefore, we propose to
examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded,
placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at
3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several
secondary outcome measures to determine the possibility of improved outcome in those infants
assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will
have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus
infants who receive placebo.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05544097 -
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
|
N/A | |
| Recruiting |
NCT03210831 -
Early Predictors of Necrotizing Enterocolitis in Neonates
|
||
| Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
| Recruiting |
NCT02552706 -
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
|
N/A | |
| Completed |
NCT02400697 -
Placental Transfusion Project for Preterm Infants
|
N/A | |
| Completed |
NCT01751477 -
Infloran® for Prevention of Necrotizing Enterocolitis
|
N/A | |
| Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
| Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
| Recruiting |
NCT01441739 -
Intestinal Failure in Necrotising Enterocolitis
|
N/A | |
| Recruiting |
NCT03869827 -
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
|
||
| Recruiting |
NCT04074824 -
A Genome-Wide Association Study for Neonatal Diseases
|
||
| Terminated |
NCT03320785 -
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
|
||
| Active, not recruiting |
NCT03554278 -
Alteration of Stool Microbiota in Preterm Infants With Anemia
|
||
| Not yet recruiting |
NCT04541771 -
The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
|
Phase 2 | |
| Not yet recruiting |
NCT03700957 -
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
|
N/A | |
| Completed |
NCT03551600 -
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
|
||
| Completed |
NCT01735578 -
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
|
N/A | |
| Unknown status |
NCT01807858 -
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
|
N/A | |
| Completed |
NCT01745510 -
Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 |