Metabolism and Toxicity of Acetaminophen in Preterm Infants
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- primary endpoint PK analysis
Study Overview
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.
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Weeks to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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
Intervention: Acetaminophen/APAP (Drug)
Outcomes
Primary Outcomes
primary endpoint PK analysis
Time Frame: 48 hours
Blood and urine levels of APAP and metabolites
Secondary Outcomes
- Developmental stage(48 hours)
Investigators
John van den Anker
MD
Children's National Research Institute