Metabolism and Toxicity of Acetaminophen

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01328808

Run by

John van den Anker

People needed

31

Starts

2011-10-01

Expected to finish

2022-12-01

Last updated by the study team

2022-03-02

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Childrens Research Institute — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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