NCT00005889

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

June 2, 2000

Last Update Submit

June 23, 2005

Conditions

Infant, Low Birth WeightHyperglycemia

Keywords

endocrine disordershyperglycemialow birth weightneonatal disordersrare disease

Interventions

alanineDRUG
amino acidsDRUG
glucagonDRUG
glucoseDRUG
glutamineDRUG
glycerolDRUG
insulinDRUG
leucineDRUG
lipidsDRUG
ureaDRUG

Eligibility Criteria

Age4 Days - 6 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

HyperglycemiaEndocrine System DiseasesInfant, Newborn, DiseasesRare Diseases

Interventions

AlanineAmino AcidsGlucagonGlucoseGlutamineGlycerolInsulinLeucineLipidsUrea

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesHexosesMonosaccharidesSugarsCarbohydratesAmino Acids, BasicAmino Acids, DiaminoAmino Acids, NeutralTriose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsProinsulinInsulinsAmino Acids, Branched-ChainAmino Acids, EssentialAmides

Study Officials

  • Agneta L. Sunehag

    Baylor College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 2, 2000

First Posted

June 5, 2000

Study Start

October 1, 1999

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)