UnknownPhase 2/3

Metabolism and Toxicity of Acetaminophen

United States31 participantsStarted 2011-10

Plain-language summary

The purpose of this study is to investigate how acetaminophen (APAP) is released into the urine and blood; to determine how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; to decrease adverse drug reactions; and to collect data on how the genetic make-up or characteristics affect how APAP is handled within the preterm infant. By taking several blood and urine samples during the study, we will be able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.

Who can participate

Age range22 Weeks – 37 Weeks

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: * Preterm and term neonates of both genders and all races * a postnatal age of less than 28 days * GA's of from 22 to less than 37 weeks * an indwelling (peripheral or umbilical) arterial line * a clinical indication for intravenous administration of pain relief medication Exclusion Criteria: * Neonates with severe asphyxia * grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations (e.g., cleft lip and palate), * neurological disorders * those receiving continuous or intermittent neuromuscular blockers * clinical or biochemical evidence of hepatic renal failure (including systemic hypoperfusion)

What they're measuring

primary endpoint PK analysis

Timeframe: 48 hours

Trial details

NCT IDNCT01328808

SponsorJohn van den Anker

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10

View on ClinicalTrials.gov More Pain trials