Metabolism and Toxicity of Acetaminophen

John van den Anker31 enrolled

Overview

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.

Study procedures: The decision to replace standard intravenous morphine therapy with APAP will be made by the attending neonatologist. Length of participation: 60 hours. No patient will be prescribed the medication specifically for the study purposes in the study protocol.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Acetaminophen/APAPDRUG

In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 37 Weeks

Medical Language ↔ Plain English

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)

Locations (2)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Childrens Research Institute

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

primary endpoint PK analysis

Blood and urine levels of APAP and metabolites

Time frame: 48 hours

Secondary Outcomes

Developmental stage

To assess both the magnitude and statistical significance of any evidence of relationship between developmental stage and toxicity-associated metabolite levels. The analyses will also hold constant APAP dose, BID or TID and possible confounding variables such as birth order, maternal smoking status, and maternal age. We will plot the relationship between stage of development and measures of APAP Metabolism, taken at different gestational and postnatal ages. A hierarchical, cross sectional time series models will be used.

Time frame: 48 hours

Data from ClinicalTrials.gov

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