Remifentanil for endotracheal intubation in neonates: a dose-finding trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Ziekenhuis Gent

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

26 Dec 2023 → ongoing

Decision date (initial)

2023-01-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ghent University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

Because data on optimal remifentanil dosing and its pharmacodynamic effects (PD) in preterm and term neonates are limited we will perform a prospective dose-finding study with PD assessment in neonates receiving remifentanil as premedication for semi-elective endotracheal intubation.
The primary outcome measure is to determine the age-specific bolus dose of remifentanil (ED90) that provides adequate intubating conditions (effective sedation) in 90% of subjects with minimal side effects.

Secondary objectives 3

1. The incidence of adverse effects.
2. Description of the procedure.
3. Variation of physiological parameters and aEEG signal.

Conditions and MedDRA coding

Hemodynamic stable term and preterm neonates requiring semi-elective endotracheal intubation.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Hemodynamic stable term or preterm neonate (normal mean blood pressure, without use of inotropic agents or vasopressors.
2. Requiring semi-elective endotracheal intubation.
3. Minimum of 26 weeks gestational age.
4. Written informed consent obtained from the legal representatives.

Exclusion criteria 8

1. 5th min Apgar score less than 5.
2. Maxillofacial anomalies.
3. Anticipated difficult airwaiy (e.g. airway anomaly or obstruction).
4. Concurrent or recent intravenous opioids infusions within 24 hours of the procedure.
5. Neonates from non-Dutch speaking parents
6. Infants born via cesarian section under general anesthesia 12 hours prior to enrollment.
7. Neonates from mothers with recent drug abuse
8. Prior enrollment in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items.
2. The level of sedation is assessed with a sedation score (adopted from the study of Naulaers et al) performed by rubbing the sole of the subject’s foot and judging the motor reaction to that stimulus (1 = spontaneous movement; 2 = movement on slight touch; 3 = movement in reaction to firm stimulus; 4 = no movement).

Secondary endpoints 3

1. safety end points: During the intubation procedure: predefined side effects such as bradycardia (heart rate less than 100 bpm), hypotension, respiratory depression, and chest wall rigidity are reviewed..
2. efficacy end points: ease of bag-mask ventilation and time to successful intubation
3. additional end points: time to return of spontaneous ventilation ; incidence of intraventricular hemorrhage ; blood gas values ; need for rescue medication

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Gent

Sponsor organisation

Universitair Ziekenhuis Gent

Address

Corneel Heymanslaan 10

City

Gent

Postcode

9000

Country

Belgium

Scientific contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Lara Garabedian

Public contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Lara Garabedian

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications