Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

NCT ID: NCT00647036

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Infants Requiring Total Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Dipeptiven (L-glutamine- Lalanine)

Group Type ACTIVE_COMPARATOR

Dipeptiven (L-glutamine- Lalanine)

Intervention Type DRUG

0.6g/kg/day

2

Isonitrogenous Vaminolact

Group Type PLACEBO_COMPARATOR

Isonitrogenous Vaminolact

Intervention Type DIETARY_SUPPLEMENT

Isonitrogenous Vaminolact

Interventions

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Isonitrogenous Vaminolact

Isonitrogenous Vaminolact

Intervention Type DIETARY_SUPPLEMENT

Dipeptiven (L-glutamine- Lalanine)

0.6g/kg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Child Health, 30 Guilford Street

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 31502272 (View on PubMed)

Other Identifiers

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07SG10

Identifier Type: -

Identifier Source: org_study_id

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