Sepsis Clinical Trial
— pretermOfficial title:
Effect of Early Enteral Supplementation of L-arginine and Glutamine on Preterm Neonate
Verified date | April 2014 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Health and Population |
Study type | Interventional |
effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates via its role as a NO precursor. Also, enteral glutamine which may play a role as an immunomodulator on preterm neonates. all these had never been studied in developing countries where sepsis and nec act as a major participant in mortality rates.
Status | Completed |
Enrollment | 75 |
Est. completion date | March 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: -Gestational age =34 weeks Exclusion Criteria: - Severe congenital anomalies. - Congenital non-bacterial infection - Evidence of intraventricular hemorrhage (IVH) grade =II on cranial ultrasound scan by day 3 of life - Conjugated hyperbilirubinemia - Evidence of an inborn error of metabolism - Exchange transfusion during the study period |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Egypt | NICU of Children hospital and Nicu of obstetric and gynecology hospital, ain shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Shah P, Shah V. Arginine supplementation for prevention of necrotising enterocolitis in preterm infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004339. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NEC incidence, stage and outcome | determining the incidence, stage and outcome of NEC in both l-arginine receiving and control groups | age of 28 days of life | Yes |
Secondary | Sepsis | incidence, severity and outcome of sepsis age at reaching full enteral intake | age of 28 days of life | Yes |
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