At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,433 enrolled

Drug / intervention

Glutamine +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005775

NCT00005775Phase 3Completed

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Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants

NICHD Neonatal Research Network·interventional·Posted Jun 2, 2000·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Glutamine and Placebo for Infant, Newborn and 4 related conditions. Completed, enrolled 1,433 participants across 15 sites.

Detailed Summary

This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 1999

First PostedJun 2000

Primary CompletionDec 2000

Study CompletionAug 2001

TodayJul 2026

First PostedJun 2, 2000

Enrollment StartJul 1, 1999

Primary CompletionDec 1, 2000

Study CompletionAug 1, 2001

TodayJul 1, 2026

Enrollment to primary: 1.4 yearsPosted 26.1 years ago

Interventions

Glutaminedrug

Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.

Placebodrug

TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.