Trial Outcomes & Findings for Exploratory Propofol Dose Finding Study In Neonates (NCT NCT01621373)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

1 hour after propofol administration

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Propofol All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. propofol administration: Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exploratory Propofol Dose Finding Study In Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol n=50 Participants All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. propofol administration: Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Age, Categorical <=18 years	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	1 day n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment Belgium	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour after propofol administration

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Stratum 1 n=12 Participants Postmenstrual age \< 28 w Postnatal age \< 10 days	Stratum 3 n=23 Participants Postmenstrual age 28 to\< 32 w Postnatal age \< 10 days	Stratum 5 n=12 Participants Postmenstrual age 32 to \< 37 w Postnatal age \< 10 days	Group 4 Postmenstrual age \>or = 37 w
Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure	0.792 mg/kg Interval 0.392 to 1.192	0.713 mg/kg Interval 0.424 to 1.002	1.350 mg/kg Interval 0.932 to 1.767	—

OTHER_PRE_SPECIFIED outcome

Timeframe: After final intubation.

Intubation condition score at final intubation was assessed retrospectively by the intubating physician. The score as described by Viby-Mogensen was used, with the evaluation of laryngoscopy, vocal cords, coughing, jaw relaxation and limb movements. The minimum score of the intubation condition score is 5, the maximum score of the intubation condition score is 20. A score less or equal to 10 defines a good intubation condition.

Outcome measures

Outcome measures
Measure	Stratum 1 n=12 Participants Postmenstrual age \< 28 w Postnatal age \< 10 days	Stratum 3 n=24 Participants Postmenstrual age 28 to\< 32 w Postnatal age \< 10 days	Stratum 5 n=12 Participants Postmenstrual age 32 to \< 37 w Postnatal age \< 10 days	Group 4 n=2 Participants Postmenstrual age \>or = 37 w
Intubation Condition Score	7 score on a scale Interval 5.0 to 13.0	6 score on a scale Interval 5.0 to 11.0	8 score on a scale Interval 5.0 to 11.0	8 score on a scale Interval 7.0 to 9.0

Adverse Events

All Particpants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Liesbeth Thewissen, MD, PhD

UZ Leuven, NICU

Phone: 003216343211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place