Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Ain Shams University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT01263041
First received: December 17, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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/Pulmonary Hypertension/Intracranial Haemorrhage/RDS
 Drug: enteral glutamine
Drug: l-arginine
Other: placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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 recieving and control groups

  • sepsis incidence, severity and outcome [ Time Frame: age of 28 days of life ] [ Designated as safety issue: No ]
    determining the incidence, stage and outcome of sepsis in both glutamine recieving and control groups


Secondary Outcome Measures:
  • incidence, severity and outcome of RDS, pulmonary hypertension, intracranial haemorrhage [ Time Frame: age of 28 days of life ] [ Designated as safety issue: Yes ]
    incidence, severity and oucome of RDS, pulmonary hypertension, intracranial haemorrhage in the 2 studed groups compared to control


Estimated Enrollment: 75
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: glutamine, PT, sepsis
effect of enteral glutamine on incidence, severity and outcome of sepsis in PT neonate
 Drug: enteral glutamine
early enteral glutamine supplementation of VLBW and effect on 1ry and 2ry outcomes
Placebo Comparator: placebo
after been randomized, will receive nothing and observed for the same outcomes
 Other: placebo
after randomization by blocks, this group will receive nothing and will be obeserved for effect on 1ry and 2ry outcomes
Active Comparator: L-arginine,NEC, PT
effect of l-arginine on incidence, severity and outcome of NEC in preterm neonate
 Drug: l-arginine
early enteral l-arginin supplementation of VLBW and effect on 1ry and 2ry outcomes

  Eligibility

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

Inclusion Criteria:

  • Gestational age ≤34 weeks
  • Birth weight ≤ 1500 gm

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
  • Pre-existing kidney failure (<0.5 mL /kg per hour urine for >8 hours).
  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 Not yet recruiting
Cairo, Egypt, 11566
Contact: hesham abdelsamie awad, Professor     0101433165 ext 002     hawad2007@yahoo.com    
Contact: maha m. hassan, Ass.Professor     0105287175 ext 002     dr_mhassan21@yahoo.com    
Principal Investigator: Ghada a. saleh, ass.lecturer            
Sponsors and Collaborators
Ain Shams University
  More Information

Additional Information:
Glutamine in the Fetus and Critically Ill Low Birth Weight Neonate:  This link exits the ClinicalTrials.gov site
Glutamine-enriched enteral nutrition in very low birth weight  This link exits the ClinicalTrials.gov site
Arginine supplementation for prevention of necrotising enterocolitis in preterm infants.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Hesham Awad
ClinicalTrials.gov Identifier: NCT01263041     History of Changes
Other Study ID Numbers: ghada a. saleh MD protocol
Study First Received: December 17, 2010
Last Updated: December 17, 2010
Health Authority: Egypt: Ministry of Health and Population

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

Additional relevant MeSH terms:
Hemorrhage
Hypertension
Hypertension, Pulmonary
Sepsis
Intracranial Hemorrhages
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013