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Cysteine Supplementation in Critically Ill Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254176
Recruitment Status : Unknown
Verified February 2010 by University of California, Los Angeles.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2005
Last Update Posted : February 26, 2010
Information provided by:
University of California, Los Angeles

Brief Summary:

Critically ill babies less than 1 month of age have deficient amounts of the antioxidant glutathione and a high incidence of disease associated with oxidative injury compared to healthy babies. These diseases include but are not limited to damage to the eyes, lungs, and intestines. Frequently becoming chronic and potentially life threatening, these diseases result in a significantly decreased quality of life to the infant along with increased costs to the infant's family and society.

The amino acid cysteine comprises a third of the tripeptide glutathione and directly influences glutathione production. Older children ill with infection and stable, premature neonates administered cysteine supplementation to their diet have been previously shown to increase their glutathione production and concentrations. Furthermore, cysteine supplementation in the ill children resulted in a quicker resolution of their illness.

Although most critically ill babies require IV nutrition (i.e., TPN) before and during their illness, commercially available TPN does not include cysteine as a significant nutrient. Cysteine has effectively become a safe and standard supplement to routine TPN in a few major hospitals in the U.S.

The purpose of this study is to evaluate the ability of cysteine supplementation to increase glutathione production and concentrations in critically ill babies. Furthermore, the investigators want to evaluate whether cysteine supplementation results in less oxidative tissue injury and ultimately less severe illnesses. The study will enroll babies admitted to the UCLA Medical Center Neonatal Intensive Care Unit (NICU) and they will be chosen at random and in a blinded fashion to receive either cysteine or non-cysteine supplementation to their routine TPN. Small blood samples along with a single 6 hour infusion of a non-radioactive, stable isotope labeled amino acid will be used to measure the production of glutathione as well as other compounds in the blood to give a quantitative assessment to the severity of illness. Clinical information relevant to the babies' illness and subsequent recovery will be recorded.

The results will be compared between cysteine vs. non-cysteine groups and before vs. after individual supplementation. By demonstrating the effect of cysteine supplementation on glutathione production, the incidence and/or severity of disease from oxidative injury in critically ill babies may be decreased if glutathione production is improved.

Condition or disease Intervention/treatment Phase
Sepsis Bronchopulmonary Dysplasia Necrotizing Enterocolitis Retinopathy of Prematurity Systemic Inflammatory Response Syndrome Dietary Supplement: Parenteral cysteine-HCl supplementation Dietary Supplement: Placebo - added premasol Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Cysteine Supplementation on Glutathione Production in Critically Ill Neonates
Study Start Date : September 2006
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : July 2011

Arm Intervention/treatment
Active Comparator: Cysteine
Subjects that receive cysteine
Dietary Supplement: Parenteral cysteine-HCl supplementation
cysteine-HCl supplementation 121 mg per kg per day

Placebo Comparator: No-cysteine placebo
Subjects that do not receive cysteine but an isonitrogenous placebo
Dietary Supplement: Placebo - added premasol
Premasol 121 mg per kg per day
Other Name: Trophamine

Primary Outcome Measures :
  1. Total RBC glutathione [ Time Frame: 0 days, 7 days, 60 days ]

Secondary Outcome Measures :
  1. Tumor necrosis factor (TNF) [ Time Frame: 0 days, 7 days, 60 days ]
  2. Interleukin-6 (IL-6) [ Time Frame: 0 days, 7 days, 60 days ]
  3. Oxygen dependency [ Time Frame: through to discharge ]
  4. Ventilation dependency [ Time Frame: through to discharge ]
  5. Erythrocyte oxidized:reduced glutathione ratio [ Time Frame: 0 days, 7 days, 60 days ]
  6. In vivo erythrocyte glutathione synthetic rate [ Time Frame: 7 days, 60 days ]
  7. Plasma malondialdehyde concentration [ Time Frame: 0 days, 7days, 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • mechanically ventilated neonates of all gestational ages and birth weights
  • less than 1 month of postnatal age admitted to the NICU
  • SNAP (Score of Neonatal Acute Physiology) > 10
  • projected requirement for continued parenteral nutrition of at least 1 week duration

Exclusion Criteria:

  • renal or hepatic failure
  • requiring insulin administration
  • requiring extracorporeal life support
  • known inherited metabolic disorders
  • known uniformly fatal congenital anomalies

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 identifier (NCT number): NCT00254176

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United States, California
UCLA Medical Center, Mattel Childrens Hospital
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Stephen B Shew, M.D. University of California, Los Angeles

Additional Information:

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Responsible Party: Stephen B. Shew, M.D., UCLA School of Medicine Identifier: NCT00254176     History of Changes
Other Study ID Numbers: 04-12-035-05
5K08HD052885-04 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010
Keywords provided by University of California, Los Angeles:
Stable Isotope
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Systemic Inflammatory Response Syndrome
Pathologic Processes
Retinal Diseases
Eye Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases