Preterm InfantsPhase 1/2NCT01713127
Remifentanil in Ventilated Preterm Infants
A Phase 1/2 study testing remifentanil infusion in people with Preterm Infants and Mechanical Ventilator Care, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Preterm Infants, Mechanical Ventilator Care
- What is being tested?
- remifentanil infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Feb 2013
- Phase
- Phase 1/2
- 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 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants (<37weeks of gestational age)
- requiring ventilator care
- informed consent
Who cannot join
- major anomaly
- 48hrs after birth
- requiring operation during drug infusion
- cord blood pH < 7.0
- intraventricular hemorrhage grade III or more
- investigators decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Official title: Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants
- Conditions
- Preterm Infants, Mechanical Ventilator Care
- Being tested
- remifentanil infusion, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanil infusionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth Receives: Drug: Placebo |
| remifentanil | Active comparator | 0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth Receives: Drug: remifentanil infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
premature infant pain profile (PIPP)
PIPP measure during tracheal suction window period ; +/- 1hr
Measured: 24hours after remifentanil/placebo infusion
Secondary outcomes (8)
intraventricular hemorrhage
intraventricular hemorrhage documented by sonography
Measured: up to 1 week of age
pneumothorax
pneumothorax documented by X-ray or sonography
Measured: up to 1 week of age
bronchopulmonary dysplasia
O2 dependency
Measured: 28 days of age
duration of ventilator care
mechanical ventilator dependency
Measured: up to 4 months of age
hospital day
days from admission to discharge from neonatal intensive care unit
Measured: upto 4 months of age
time to full feeding
day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
Measured: up to 2 months of age
mortality
in-hospital death
Measured: up to 4 months of age
development of adverse effects
category of adverse effects
- General appearance Fever or Hypothermia, Rash
- Respiratory \& Cardiovascular Arrhythmia Tachypnea (RR >100/min) Desaturation (SpO2 <80%) Hypotension (inotropics use or need volume challenge) Bradycardia (HR <80/min) Tachycardia (HR >200/min)
- Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis
- Renal Oliguria (U/O < 1.0cc/kg/day)
- Neurologic Seizure Cerebral infarction
Measured: from the start of remifentanil infusion to 1 hour after end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: declined enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine, DongGuk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713127
- Sponsor's protocol ID
- RFTN-02
- Other IDs
- 12077
- Status last verified
- Oct 2012
- First submitted
- 31 Aug 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
- ClinicalTrials.gov ID
- NCT01713127
- Acronym / sponsor ID
- RFTN-02
- Conditions
- Preterm Infants, Mechanical Ventilator Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: declined enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ajou University School of Medicine, DongGuk University
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Oct 2012 (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 evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth |
| remifentanil | Active comparator | Drug: remifentanil infusion0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants (<37weeks of gestational age)
- requiring ventilator care
- informed consent
Key exclusion criteria (6 listed)
- major anomaly
- 48hrs after birth
- requiring operation during drug infusion
- cord blood pH < 7.0
- intraventricular hemorrhage grade III or more
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 |
|---|---|---|
| remifentanil infusion | Drug | remifentanil |
| Placebo | Drug | Placebo |
Primary outcome
premature infant pain profile (PIPP)
Time frame: 24hours after remifentanil/placebo infusion
PIPP measure during tracheal suction window period ; +/- 1hr
8 secondary outcomes
intraventricular hemorrhage
Time frame: up to 1 week of age
pneumothorax
Time frame: up to 1 week of age
bronchopulmonary dysplasia
Time frame: 28 days of age
duration of ventilator care
Time frame: up to 4 months of age
hospital day
Time frame: upto 4 months of age
time to full feeding
Time frame: up to 2 months of age
mortality
Time frame: up to 4 months of age
development of adverse effects
Time frame: from the start of remifentanil infusion to 1 hour after end of infusion
Results and safety
The study was stopped early (reason given: declined enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing remifentanil infusion in people with Preterm Infants and Mechanical Ventilator Care, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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: stopped early, as of the sponsor's last update on 20 Nov 2015. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: declined enrollment). Results are not available in the source record.
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?
premature infant pain profile (PIPP) (time frame: 24hours after remifentanil/placebo infusion). 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 20 Nov 2015.