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Metabolism and Toxicity of Acetaminophen

This study is currently recruiting participants.
Verified August 2017 by John van den Anker, Children's Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328808
First Posted: April 5, 2011
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
John van den Anker, Children's Research Institute
March 30, 2011
April 5, 2011
August 22, 2017
October 2011
June 2019   (Final data collection date for primary outcome measure)
primary endpoint PK analysis [ Time Frame: 48 hours ]
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 ]

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
Intervention Model: Single Group Assignment
Masking: None (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2019
June 2019   (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)
Sexes Eligible for Study: All
22 Weeks to 37 Weeks   (Child)
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: There is no plan to share individual participant data. Preliminary data published Published manuscripts in 2015 & 2016
John van den Anker, Children's Research Institute
John van den Anker
Not Provided
Principal Investigator: John N van den Anker, MD, PhD Children's Research Institute
Children's Research Institute
August 2017

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