NCT00647036

Brief Summary

We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2.4 years

First QC Date

March 26, 2008

Last Update Submit

January 19, 2022

Conditions

Surgical Infants Requiring Total Parenteral Nutrition

Keywords

Parenteral nutrition, Infants, Dipeotiven, Microbial invasion

Outcome Measures

Primary Outcomes (1)

  • Evidence of microbial invasion

    5 days

Study Arms (2)

1

ACTIVE COMPARATOR

Dipeptiven (L-glutamine- Lalanine)

Drug: Dipeptiven (L-glutamine- Lalanine)

2

PLACEBO COMPARATOR

Isonitrogenous Vaminolact

Dietary Supplement: Isonitrogenous Vaminolact

Interventions

Isonitrogenous VaminolactDIETARY_SUPPLEMENT

Isonitrogenous Vaminolact

2
Dipeptiven (L-glutamine- Lalanine)DRUG

0.6g/kg/day

1

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants who have undergone surgical procedures for congenital anomalies or
  • Intestinal inflammation who require total parenteral nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health, 30 Guilford Street

London, WC1N 1EH, United Kingdom

Location

Related Publications (1)

  • Bishay M, Simchowitz V, Harris K, Macdonald S, De Coppi P, Klein N, Eaton S, Pierro A; MIGS Trial Group. The Effect of Glutamine Supplementation on Microbial Invasion in Surgical Infants Requiring Parenteral Nutrition: Results of a Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Jan;44(1):80-91. doi: 10.1002/jpen.1700. Epub 2019 Sep 9.

    PMID: 31502272RESULT

MeSH Terms

Conditions

Hyperphagia

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

GB(1)