Recruiting

Observational Study

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00005889

Conditions

Infant, Low Birth Weight

Hyperglycemia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

alanine

amino acids

glucagon

glucose

glutamine

Study Details

Brief summary:

RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known.

PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.

Conditions

Infant, Low Birth Weight

Hyperglycemia

Study ID

NCT00005889

Start date

Oct, 1999

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

  • Clinically stable, very low birth weight infants (750-1,500 grams)
  • Normal blood glucose values OR Blood glucose greater than 175 mg/dL
  • No prior insulin
  • No sepsis Oxygen supply less than 30% Normal acid base status
  • No malformation
  • No discernible diseases

Study Design

Enrollment

96 participants

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

alanine

amino acids

glucagon

glucose

glutamine

glycerol

insulin

leucine

lipids

urea

Central Contacts and Locations

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Agneta L. Sunehag

713-798-6725asunehag@bcm.tmc.edu

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

  • endocrine disorders
  • hyperglycemia
  • low birth weight
  • neonatal disorders
  • rare disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.