Effect of L-arginine and Glutamine on Preterm

NCT01263041 | Completed Phase 2 DMC

• 1 other identifier: ghada a. saleh MD protocol
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

NEC; Sepsis

Keywords

Glutamine, NEC, L-arginine,Preterm,Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sepsis

  age of 28 days of life

Study Arms (3)

glutamine, PT, sepsis

EXPERIMENTAL

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

Control

NO INTERVENTION

after been allocated, will receive nothing and observed for the same outcomes

L-arginine,NEC, PT

EXPERIMENTAL

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

Interventions

Glutamine DRUG

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

Also known as: Pure a.a. chemical

glutamine, PT, sepsis

l-arginine DRUG

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

Also known as: pure a.a. chemical

L-arginine,NEC, PT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age ≤34 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

NICU of Children hospital and Nicu of obstetric and gynecology hospital, ain shams university

Cairo, 11566, Egypt

Location

Related Publications (2)

• Shah P, Shah V. Arginine supplementation for prevention of necrotising enterocolitis in preterm infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004339. doi: 10.1002/14651858.CD004339.pub3.

  PMID: 17636753 RESULT

• El-Shimi MS, Awad HA, Abdelwahed MA, Mohamed MH, Khafagy SM, Saleh G. Enteral L-Arginine and Glutamine Supplementation for Prevention of NEC in Preterm Neonates. Int J Pediatr. 2015;2015:856091. doi: 10.1155/2015/856091. Epub 2015 Mar 12.

  PMID: 25861285 DERIVED

Related Links

• Glutamine-enriched enteral nutrition in very low birth weight
• Arginine supplementation for prevention of necrotising enterocolitis in preterm infants.

MeSH Terms

Conditions

Sepsis; Enterocolitis, Necrotizing

Interventions

Glutamine; Arginine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Amino Acids, Essential

Study Officials

• GHada A. Saleh, MRCPCH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: G. Saleh

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 20, 2010
• Study Start: May 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

EG (1)