Effect of L-arginine and Glutamine on Preterm (preterm)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ghada saleh, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01263041
First received: December 17, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
NEC
Sepsis
Drug: Glutamine
Drug: l-arginine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Early Enteral Supplementation of L-arginine and Glutamine on Preterm Neonate

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • NEC incidence, stage and outcome [ Time Frame: age of 28 days of life ] [ Designated as safety issue: Yes ]
    determining the incidence, stage and outcome of NEC in both l-arginine receiving and control groups


Secondary Outcome Measures:
  • Sepsis [ Time Frame: age of 28 days of life ] [ Designated as safety issue: Yes ]
    incidence, severity and outcome of sepsis age at reaching full enteral intake


Enrollment: 75
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glutamine, PT, sepsis
enteral or via NG tube dose of 312mg/kg/day divided every 12 hours from starting feeding up to 30 says post natal age + usual care and medications
Drug: Glutamine
enteral or via NG tube dose of 312mg/kg/day divided every 12 hours from starting feeding + usual care and medications up to 30 says post natal age
Other Name: Pure a.a. chemical
No Intervention: Control
after been allocated, will receive nothing and observed for the same outcomes
Experimental: L-arginine,NEC, PT
enteral or via NG tube dose of 260 mg/kg/day divided every 12 hours from starting feeding up to 30 says post natal age + usual care and medications
Drug: l-arginine
enteral or via NG tube dose of 260mg/kg/day divided every 12 hours from starting feeding + usual care and medications up to 30 says post natal age
Other Name: pure a.a. chemical

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263041

Locations
Egypt
NICU of Children hospital and Nicu of obstetric and gynecology hospital, ain shams university
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: GHada A. Saleh, MRCPCH Ain Shams University
  More Information

Additional Information:
Publications:
Responsible Party: ghada saleh, G. Saleh, Ain Shams University
ClinicalTrials.gov Identifier: NCT01263041     History of Changes
Other Study ID Numbers: ghada a. saleh MD protocol
Study First Received: December 17, 2010
Last Updated: April 14, 2014
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Ain Shams University:
Glutamine, NEC, L-arginine,Preterm,Sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014