Necrotizing Enterocolitis Clinical Trial
With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.
Status | Completed |
Enrollment | 93 |
Est. completion date | August 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 1 Month |
Eligibility |
Inclusion Criteria: - premature neonates < 33 weeks gestational age Exclusion Criteria: - major congenital anomalies - prior use of cytokines |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). | one month | No | |
Primary | Time to stop parentral nutrition | one month | No | |
Primary | Day of onset of weight gain | one month | No | |
Primary | Duration of hospitalization | 2 months | No | |
Secondary | Necrotizing enterocolitis (NEC)stage (if any) | Bell and colleagues proposed a clinical staging system for NEC: infants with suspected NEC (stage I), definite NEC (stage II), or advanced NEC (stage III) (Bell et al., 1978). | 2 months | Yes |
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 | |
Terminated |
NCT01156480 -
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
|
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 |
NCT04074824 -
A Genome-Wide Association Study for Neonatal Diseases
|
||
Recruiting |
NCT03869827 -
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
|
||
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 |
NCT01745510 -
Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates
|
Phase 1/Phase 2 | |
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 |