Metabolism and Toxicity of Acetaminophen

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01328808
First received: March 30, 2011
Last updated: September 12, 2014
Last verified: September 2014

March 30, 2011
September 12, 2014
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 ClinicalTrials.gov 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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Acetaminophen/APAP

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

Other Name: Tylenol
Experimental: group 2 Pain management

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 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute

Intervention: Drug: Acetaminophen/APAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2016
June 2016   (final data collection date for primary outcome measure)

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)
Both
22 Weeks to 37 Weeks
No
Contact: Elaine F Williams, PhD, RN 202 476 2245 efwillia@cnmc.org
Contact: Ruby M Daniels 2024762176 rmdaniel@cnmc.org
United States
 
NCT01328808
4839 - APAP
No
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
September 2014

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