Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

NICHD Neonatal Research Network

Status and phase: Completed; Phase 3

Conditions: Infant, Low Birth Weight; Infant, Newborn; Infant, Small for Gestational Age; Infant, Premature; Sepsis

Treatments: Drug: Glutamine; Drug: Placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00005775

M01RR000997 (U.S. NIH Grant/Contract)

U10HD021373 (U.S. NIH Grant/Contract)

U10HD021415 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U10HD034167 (U.S. NIH Grant/Contract)

M01RR000070 (U.S. NIH Grant/Contract)

M01RR006022 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

NICHD-NRN-0020

M01RR000750 (U.S. NIH Grant/Contract)

U10HD027881 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

M01RR001032 (U.S. NIH Grant/Contract)

M01RR008084 (U.S. NIH Grant/Contract)

U01HD036790 (U.S. NIH Grant/Contract)

U10HD034216 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

U10HD027871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,433 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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1,433 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Description:

TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)

Treatment:

Drug: Glutamine

Placebo

Placebo Comparator group

Description:

Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids)

Treatment:

Drug: Placebo