TerminatedNot Applicable

A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months

Stopped: PI has retired and had trouble recruiting babies

Canada2 participantsStarted 2016-02

Plain-language summary

This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.

Who can participate

Age range1 Month – 6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between ages 1 - 6 months * Born between 32 and 43 weeks gestational age * Clinically stable (normal vital signs and blood values) * Fed by nasogastric (NG), jejunal (J or NJ), or gastric (G) tube Exclusion Criteria: * Infants will be excluded if they are receiving supplemental oxygen * Mechanically ventilated * Have any endocrine or genetic anomalies that affect protein or AA metabolism * On medications that influence protein and AA metabolism (ex: corticosteroid therapy)

What they're measuring

Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months

Timeframe: 12 months

Trial details

NCT IDNCT02364843

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10

View on ClinicalTrials.gov More Surgical Infants on NG/NJ/J/G-tube Feeds trials