Metabolism and Toxicity of Acetaminophen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Acetaminophen/APAP

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Tylenol

Eligibility Criteria

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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)

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No