Metabolism and Toxicity of Acetaminophen

Sponsor

John van den Anker (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01328808

Collaborator

(none)

Enrollment

Locations

Arm

134

Anticipated Duration (Months)

15.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Metabolism and Toxicity of Acetaminophen in Preterm Infants

Actual Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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 Names: Tylenol

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 Names:

Tylenol

Outcome Measures

Primary Outcome Measures

primary endpoint PK analysis [48 hours]
Blood and urine levels of APAP and metabolites

Secondary Outcome Measures

Developmental stage [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's National Medical Center	Washington	District of Columbia	United States	20010
2	Childrens Research Institute	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

John van den Anker

Investigators

Principal Investigator: John N van den Anker, MD, PhD, Children's National Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John van den Anker, MD, Children's National Research Institute

ClinicalTrials.gov Identifier:

NCT01328808

Other Study ID Numbers:

4839 - APAP

First Posted:

Apr 5, 2011

Last Update Posted:

Mar 2, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by John van den Anker, MD, Children's National Research Institute

Acetaminophen

Preterm Infants

Additional relevant MeSH terms:

Acetaminophen

Study Results

No Results Posted as of Mar 2, 2022