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Completed

NCT Number: NCT00005775

Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

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.

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Key information

Conditions

Infant, Newborn Female Urogenital Diseases and Pregnancy Complications Hyperphagia Infant, Low Birth Weight Infant, Premature Infant, Small for Gestational Age Infections Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Signs and Symptoms Signs and Symptoms, Digestive Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings. Glutamine, which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta, is not routinely provided in neonatal parenteral nutrition preparations.

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.

Infants received a neurodevelopmental assessment by masked, certified examiners at 18-22 months postmenstrual age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 401-1000 gm
  • More than 12 hrs and less than 72 hrs after birth; intravenous access
  • Parental consent

Exclusion criteria

  • One or more major congenital anomalies
  • Infants meeting criteria for terminal illness
  • Congenital nonbacterial infection with overt signs at birth

Treatment and study plan

glutamine

Drug

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

Other names: L-Glutamine, TrophAmine

Placebo

Drug

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

Other names: TrophAmine

Primary outcomes

  1. Death or late-onset sepsis

    Time frame: At hospital discharge

Secondary outcomes

  1. Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intolerance

    Time frame: At hospital discharge

  2. Necrotizing Enterocolitis

    Time frame: At hospital discharge

  3. Episodes of late-onset sepsis

    Time frame: At hospital discharge

  4. Growth (days to reach 1500 grams)

    Time frame: At hospital discharge

  5. Number of days on parenteral nutrition

    Time frame: At hospital discharge

  6. Length of stay in NICU

    Time frame: At hospital discharge

  7. Neurodevelopmental outcome

    Time frame: 18-22 months corrrected age

  8. Levels of pro-inflammatory cytokines

    Time frame: In the perinatal period

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Acronym: Glutamine

Important dates

Study start
1999
Primary completion
2000
Study completion
2001
First posted
Jun 2, 2000
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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