Metabolism and Toxicity of Acetaminophen

This study is currently recruiting participants.
Verified April 2012 by Children's Research Institute
Information provided by (Responsible Party):
Children's Research Institute Identifier:
First received: March 30, 2011
Last updated: April 26, 2012
Last verified: April 2012

March 30, 2011
April 26, 2012
October 2011
June 2016   (final data collection date for primary outcome measure)
primary endpoint PK analysis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Blood and urine levels of APAP and metabolites
Same as current
Complete list of historical versions of study NCT01328808 on Archive Site
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.

Same as current
Not Provided
Not Provided
Metabolism and Toxicity of Acetaminophen
Metabolism and Toxicity of Acetaminophen in Preterm Infants

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.

Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Acetaminophen

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
Experimental: group 2 Pain management
Gestational age < 28 weeks
Intervention: Drug: Acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Preterm 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)
22 Weeks to 37 Weeks
Contact: Elaine F Williams, RN, MSN 202 476 2245
Contact: Ruby M Daniels 2024762176
United States
4839 - APAP
Children's Research Institute
Children's Research Institute
Not Provided
Principal Investigator: John N van den Anker, MD, PhD Childrens Research Institute
Children's Research Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP