Trial Outcomes & Findings for SMOFlipid to Lessen the Severity of Neonatal Cholestasis (NCT NCT02721277)

NCT ID: NCT02721277

Last Updated: 2017-04-17

Results Overview

Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-04-17

Participant Flow

Participant milestones

Measure	SMOFlipid Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SMOFlipid to Lessen the Severity of Neonatal Cholestasis

Baseline characteristics by cohort

Measure	SMOFlipid n=2 Participants Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay. SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Age, Categorical <=18 years	2 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
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Growth increase will be measured by head circumference of participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Growth increase will be measured by weight of participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Growth increase will be measured by length of participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Enteral administration of formula will be noted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Enteral administration of breast milk will be noted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory values will be used to determine adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that determines acid-base balance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory values that evaluates glucose in the blood

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Laboratory value that evaluates liver function and metabolism of fat

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Length of therapy with mechanical ventilation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Length of therapy with nasal continuous positive airway pressure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Length of therapy with nasal cannula

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

A review of the subject's medical record will determine the location from which positive blood cultures were obtained.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Study was terminated due to insufficient enrollment

A review of the subject's medical record will determine the location from which positive blood cultures were obtained.

Outcome measures

Outcome data not reported

Adverse Events

SMOFlipid

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

Josef Neu, MD

University of Florida

Phone: 352-273-8985

Email: neuj@peds.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place