Mechanically Ventilated NeonatesPhase 1NCT01322204
Codeine in Mechanically Ventilated Neonates
A Phase 1 study testing Codeine in people with Mechanically Ventilated Neonates and Painful Procedures in Newborns, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Mechanically Ventilated Neonates, Painful Procedures in Newborns
- What is being tested?
- Codeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 6 Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York Downstate
Brooklyn, New York, 11203
About this study
Official title: Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates
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.
Read the detailed description
This proposal has its origins in a larger initiative to elucidate the pharmacological basis for the interindividual differences observed in opioid responsiveness. Gaps in our knowledge related to opioid disposition in newborns need to be addressed to complete the design of the required overarching initiative in which age could be treated as a continuous variable within a context of PK, PD and PG determinants.This proposal is designed to generate preliminary data that addresses two issues. First, can newborns absorb enterally administered codeine and is this ability determined by PCA or PNA age? The second relates to the ability of newborn infants to catalyze those reactions required to metabolically activate both codeine and morphine. The latter will also be evaluated within the context of PCA versus PNA age.
These data will not only fill an information gap that must be addressed before the larger initiative moves forward, but they also provide a platform for serious study of the ontogeny of certain pharmacokinetic processes that may prove critical to our understanding of newborn drug disposition. In this way, codeine can provide important insights concerning the ontogeny of drug disposition and permit the determination of the relative importance of PCA versus PNA ages to the functional expression of these processes.
- Being tested
- Codeine
- Keywords
- codeine, neonates, pediatric pharmacology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CodeineDrug
One single oral dose of 1 mg/kg of codeine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Neonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation. Receives: Drug: Codeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (1)
Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startAug 2008
- Primary completion6 Mar 2013
- Study completion6 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Jacob Aranda, State University of New York - Downstate Medical Center
- Investigators
- Jacob V Aranda, MD, PhD, Principal investigator, State University of New York Downstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322204
- Sponsor's protocol ID
- 10922
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2011
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates
- ClinicalTrials.gov ID
- NCT01322204
- Acronym / sponsor ID
- 10922
- Keywords
- codeine, neonates, pediatric pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 2008
- Primary completion
- 6 Mar 2013 (actual)
- Study completion
- 6 Mar 2013 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposal has its origins in a larger initiative to elucidate the pharmacological basis for the interindividual differences observed in opioid responsiveness. Gaps in our knowledge related to opioid disposition in newborns need to be addressed to complete the design of the required overarching initiative in which age could be treated as a continuous variable within a context of PK, PD and PG determinants.This proposal is designed to generate preliminary data that addresses two issues. First, can newborns absorb enterally administered codeine and is this ability determined by PCA or PNA age? The second relates to the ability of newborn infants to catalyze those reactions required to metabolically activate both codeine and morphine. The latter will also be evaluated within the context of PCA versus PNA age.
These data will not only fill an information gap that must be addressed before the larger initiative moves forward, but they also provide a platform for serious study of the ontogeny of certain pharmacokinetic processes that may prove critical to our understanding of newborn drug disposition. In this way, codeine can provide important insights concerning the ontogeny of drug disposition and permit the determination of the relative importance of PCA versus PNA ages to the functional expression of these processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CodeineNeonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CodeineOne single oral dose of 1 mg/kg of codeine | Drug | 1 |
Primary outcome
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.
Time frame: 2 hours
1 secondary outcome
Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob V Aranda, MD, PhD principal investigator
State University of New York Downstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Codeine in people with Mechanically Ventilated Neonates and Painful Procedures in Newborns, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.