Trial Outcomes & Findings for Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (NCT NCT02476994)

NCT ID: NCT02476994

Last Updated: 2021-07-21

Results Overview

Holman Index Calculation

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Up to 90 Days

Results posted on

2021-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Clinolipid (Lipid Injectable Emulsion, USP) 20% Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid	Intralipid 20% (Lipid Injectable Emulsion, USP) Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinolipid (Lipid Injectable Emulsion, USP) 20% Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid	Intralipid 20% (Lipid Injectable Emulsion, USP) Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion
Overall Study Based on feedback from FDA	1	0

Baseline Characteristics

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinolipid (Lipid Injectable Emulsion, USP) 20% n=1 Participants Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Clinolipid	Intralipid 20% (Lipid Injectable Emulsion, USP) Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Holman Index Calculation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 Days After Subject's Last Study Treatment

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 90 Days

Population: Due to early termination of the study, no formal analysis was conducted.

Outcome measures

Outcome data not reported

Adverse Events

Clinolipid (Lipid Injectable Emulsion, USP) 20%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intralipid 20% (Lipid Injectable Emulsion, USP)

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

Clinical Trials Disclosure Group

Baxter Healthcare

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place