Adverse Reaction to DrugPhase 2NEOPROPNCT01621373

Exploratory Propofol Dose Finding Study In Neonates

A Phase 2 study testing propofol administration in people with Adverse Reaction to Drug and Neonatal Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates). Read more about this study

Who is it for?: Ages 1 day to 28 days
Conditions the study is for: Adverse Reaction to Drug, Neonatal Disorder
What is being tested?: propofol administration
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBelgium
Study dates: Aug 2012to Jul 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 day to 28 days
All sexes
No healthy volunteers
Child

Who may be able to join

Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents.
Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.

Who cannot join

Known propofol intolerance

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Neonatal Intensive Care Unit UZ Leuven
Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates

Read the detailed description

The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous bolus. This is part of routine clinical care in patients receiving (semi-) elective intubation. It's the aim to explore the most effective IV propofol dose for a successful INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen for propofol in neonates.

Intubation condition score was assessed retrospectively by the intubating physician.

Conditions: Adverse Reaction to Drug, Neonatal Disorder
Being tested: propofol administration
Keywords: neonatology, intratracheal intubation, propofol
Medical subject headings: Drug-Related Side Effects and Adverse Reactions, Infant, Newborn, Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propofol administrationDrug
Also called Diprivan
Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.

Study groups in NCT01621373
Study group	Role	What they receive
propofol	Other	All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. Receives: Drug: propofol administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
An up-and-down dose-response design was used to calculate ED50 (mg/kg) in strata with effective sampling size of at least 6, by use of the Dixon-Massey method for small samples.
Measured: 1 hour after propofol administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jul 2014

First posted18 Jun 2012 (estimated)
Study startAug 2012
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adverse Reaction to DrugStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01621373
Sponsor's protocol ID: s54472
Other IDs: 2012-002648-26
Acronym: NEOPROP
Status last verified: Aug 2012
First submitted: 8 Jun 2012
Last updated: 30 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.
PubMed 27597733

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates
ClinicalTrials.gov ID: NCT01621373
Acronym / sponsor ID: NEOPROP / s54472
Conditions: Adverse Reaction to Drug, Neonatal Disorder
Keywords: neonatology, intratracheal intubation, propofol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Study start: Aug 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 18 Jun 2012 (estimated)
Results: Posted 30 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Intubation condition score was assessed retrospectively by the intubating physician.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
propofol	Other	Drug: propofol administrationAll patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.

Who may qualify

Ages: 1 day to 28 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents.
Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.

Key exclusion criteria (1 listed)

Known propofol intolerance

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
propofol administrationAlso: DiprivanSingle IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.	Drug	propofol

Primary outcome

Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
Time frame: 1 hour after propofol administration
An up-and-down dose-response design was used to calculate ED50 (mg/kg) in strata with effective sampling size of at least 6, by use of the Dixon-Massey method for small samples.

Results and safety

Results posted to the registry on 30 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol	50	50

Primary outcome: Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure

Time frame: 1 hour after propofol administration. Mean (95% Confidence Interval). Unit: mg/kg

Measure	Stratum 1 n = 12	Stratum 3 n = 23	Stratum 5 n = 12
Value	0.792 (0.392 to 1.192)	0.713 (0.424 to 1.002)	1.350 (0.932 to 1.767)

Population analysed: Of the 8 strata defined by postmenstrual age and postnatal age, primary outcome of propofol ED 50 in mg/dl could be calculated in stratum 1,3 and 5.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Particpants	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27597733Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.

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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.

Liesbeth Thewissen, MD principal investigator

UZ Leuven, Belgium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing propofol administration in people with Adverse Reaction to Drug and Neonatal Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 2 inclusion and 1 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 30 Jul 2024. 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 Belgium. 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 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?

Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure (time frame: 1 hour after propofol administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621373, which also lists 1 linked publication.

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 30 Jul 2024.