Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants (Glutamine)
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| ClinicalTrials.gov Identifier: NCT00005775 |
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Recruitment Status :
Completed
First Posted : June 2, 2000
Last Update Posted : June 8, 2015
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Sponsor:
NICHD Neonatal Research Network
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Sepsis | Drug: Glutamine Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1433 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants |
| Study Start Date : | July 1999 |
| Actual Primary Completion Date : | December 2000 |
| Actual Study Completion Date : | August 2001 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Glutamine
TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)
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Drug: Glutamine
Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
Other Names:
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Placebo Comparator: Placebo
Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids)
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Drug: Placebo
TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
Other Name: TrophAmine |
Primary Outcome Measures :
- Death or late-onset sepsis [ Time Frame: At hospital discharge ]
Secondary Outcome Measures :
- 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 ]
- Necrotizing Enterocolitis [ Time Frame: At hospital discharge ]
- Episodes of late-onset sepsis [ Time Frame: At hospital discharge ]
- Growth (days to reach 1500 grams) [ Time Frame: At hospital discharge ]
- Number of days on parenteral nutrition [ Time Frame: At hospital discharge ]
- Length of stay in NICU [ Time Frame: At hospital discharge ]
- Neurodevelopmental outcome [ Time Frame: 18-22 months corrrected age ]
- Levels of pro-inflammatory cytokines [ Time Frame: In the perinatal period ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 72 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005775
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| University of California at San Diego | |
| San Diego, California, United States, 92103-8774 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, North Carolina | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Investigators
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Neil N. Finer, MD | University of California, San Diego | |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami | |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico | |
| Principal Investigator: | W. Kenneth Poole, PhD | RTI International | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee | |
| Principal Investigator: | Jon E. Tyson, MD MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Abbot R. Laptook, MD | University of Texas Southwestern Medical Center | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | William Oh, MD | Women and Infants Hospital, Brown University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) infants Prematurity Glutamine |
Total parenteral nutrition Nutrition Very low birth weight (VLBW) infants |
Additional relevant MeSH terms:
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Premature Birth Birth Weight Body Weight Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Amino-acid, glucose, and electrolyte solution Parenteral Nutrition Solutions Pharmaceutical Solutions |