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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263041
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
ghada saleh, Ain Shams University

Brief Summary:
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 or disease Intervention/treatment Phase
NEC Sepsis Drug: Glutamine Drug: l-arginine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Early Enteral Supplementation of L-arginine and Glutamine on Preterm Neonate
Study Start Date : May 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. NEC incidence, stage and outcome [ Time Frame: age of 28 days of life ]
    determining the incidence, stage and outcome of NEC in both l-arginine receiving and control groups


Secondary Outcome Measures :
  1. Sepsis [ Time Frame: age of 28 days of life ]
    incidence, severity and outcome of sepsis age at reaching full enteral intake



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263041


Locations
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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
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Principal Investigator: GHada A. Saleh, MRCPCH Ain Shams University
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ghada saleh, G. Saleh, Ain Shams University
ClinicalTrials.gov Identifier: NCT01263041    
Other Study ID Numbers: ghada a. saleh MD protocol
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by ghada saleh, Ain Shams University:
Glutamine, NEC, L-arginine,Preterm,Sepsis
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes