ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolism and Toxicity of Acetaminophen

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.
ClinicalTrials.gov Identifier: NCT01328808
Recruitment Status : Recruiting
First Posted : April 5, 2011
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
John van den Anker, Children's Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Acetaminophen/APAP Phase 2 Phase 3

Detailed Description:

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolism and Toxicity of Acetaminophen in Preterm Infants
Study Start Date : October 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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



Primary Outcome Measures :
  1. primary endpoint PK analysis [ Time Frame: 48 hours ]
    Blood and urine levels of APAP and metabolites


Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328808


Contacts
Contact: Elaine F Williams, PhD, RN 202 476 2245 efwillia@cnmc.org
Contact: Ruby M Daniels 2024762176 rmdaniel@cnmc.org

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Principal Investigator: John Van den Anker, MD         
Childrens Research Institute Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Elaine F Williams, RN, MSN, PhD    202-476-2245    efwillia@cnmc.org   
Contact: Ruby M Daniels    202-476-2216    rmdaniel@cnmc.org   
Principal Investigator: John van den Anker, MD, PhD         
Sub-Investigator: Nina Deutsch, MD         
Sponsors and Collaborators
John van den Anker
Investigators
Principal Investigator: John N van den Anker, MD, PhD Children's Research Institute

Publications of Results:
Responsible Party: John van den Anker, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01328808     History of Changes
Other Study ID Numbers: 4839 - APAP
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is no plan to share individual participant data. Preliminary data published Published manuscripts in 2015 & 2016

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John van den Anker, Children's Research Institute:
Acetaminophen
Preterm Infants

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics