Codeine in Mechanically Ventilated Neonates

NCT01322204 | Completed Phase 1 DMC

• 1 other identifier: 10922
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the absorption and bioavailability of codeine in relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug (codeine), its active metabolites, their formation rates and their ratios in relation with PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study population and their potential relationship to the biodisposition and pharmacodynamic effects of codeine. The study population is intubated and mechanically ventilated infants equal to or greater than 26 weeks gestational age at birth and less than 4 weeks postnatal age.

Conditions

Mechanically Ventilated Neonates; Painful Procedures in Newborns

Keywords

codeine, neonates, pediatric pharmacology

Outcome Measures

Primary Outcomes (1)

• The rate and extent of absorption of oral codeine, the ratios of the observed concentration of each metabolite to the observed concentration of parent drug and the formation and clearances of the metabolites.

  2 hours

Secondary Outcomes (1)

• Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.

  2 hours

Study Arms (1)

1

EXPERIMENTAL

Neonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation.

Drug: Codeine

Interventions

Codeine DRUG

One single oral dose of 1 mg/kg of codeine

1

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates ≥ 26 weeks PCA receiving mechanical ventilation and painful procedure will be eligible for participation in the study
• Subject's parent/legal guardian must give written informed consent prior to study participation
• Subject is receiving opioid analgesia therapy based on caregiver determination. The ideal patient will not be receiving morphine.
• Must be able to receive an enteral dose of codeine.

You may not qualify if:

• Known hypersensitivity to morphine, fentanyl, or codeine
• Patients with ALT concentrations \>2x upper limit of normal for age or clinical evidence of hepatic failure
• Patients with serum creatinine concentrations \>2x upper limit of normal for age or clinical evidence of renal failure
• Patients who are NPO
• Babies born to maternal drug abuse.
• Total serum bilirubin level of \> 10 mg/dl or 170 umol/L.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

State University of New York Downstate

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Interventions

Codeine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jacob V Aranda, MD, PhD

  State University of New York Downstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: August 1, 2008
• Primary Completion: March 6, 2013
• Study Completion: March 6, 2013
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)