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Metabolism and Toxicity of Acetaminophen

This study is currently recruiting participants.
Verified April 2012 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: April 26, 2012
Last verified: April 2012
History of Changes
  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
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolism and Toxicity of Acetaminophen in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • primary endpoint PK analysis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Blood and urine levels of APAP and metabolites


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 2 Pain management
Gestational age < 28 weeks
 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

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328808

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

Locations
United States, District of Columbia
Childrens Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Elaine F Williams, RN, MSN     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: Mary Revenis, MD            
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: John N van den Anker, MD, PhD Childrens Research Institute
  More Information

No publications provided

Responsible Party: 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: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Research Institute:
Acetaminophen
Preterm Infants

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

ClinicalTrials.gov processed this record on May 19, 2013