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Metabolism and Toxicity of Acetaminophen

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by John van den Anker, Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
John van den Anker, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01328808
First received: March 30, 2011
Last updated: August 17, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Pain Drug: Acetaminophen/APAP Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolism and Toxicity of Acetaminophen in Preterm Infants

Resource links provided by NLM:


Further study details as provided by John van den Anker, Children's Research Institute:

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


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: John van den Anker, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01328808     History of Changes
Other Study ID Numbers: 4839 - APAP
Study First Received: March 30, 2011
Last Updated: August 17, 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

ClinicalTrials.gov processed this record on September 20, 2017