Metabolism and Toxicity of Acetaminophen
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metabolism and Toxicity of Acetaminophen in Preterm Infants|
- primary endpoint PK analysis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Blood and urine levels of APAP and metabolites
- Developmental stage [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
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.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: group 2 Pain management
Gestational age < 28 weeks
In preterm 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.
Administration of inulin:
Inulin will be administered as a glucose 10%-inulin solution containing 25 gr. inulin/L, at an infusion rate of 0.6 mL/kg/
Other Name: Tylenol
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.
|Contact: Elaine F Williams, RN, MSN||202 476 firstname.lastname@example.org|
|Contact: Ruby M Danielsemail@example.com|
|United States, District of Columbia|
|Childrens Research Institute||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Elaine F Williams, RN, MSN 202-476-2245 firstname.lastname@example.org|
|Contact: Ruby M Daniels 202-476-2216 email@example.com|
|Principal Investigator: John van den Anker, MD, PhD|
|Sub-Investigator: Mary Revenis, MD|
|Principal Investigator:||John N van den Anker, MD, PhD||Childrens Research Institute|