Trial Outcomes & Findings for Intravenous Fat Emulsions and Premature Infants (NCT NCT01096446)

Results Overview

Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

First 7 days of life

Results posted on

2014-11-20

Participant Flow

Infants with a birthweight \< 750 grams were recruited from April 2008 through March 2010 at the neonatal intensive care unit at at the Children's Hospital of Illinois at OSF Saint Francis Medical Center Peoria, IL.

Thirty-five infants were deemed eligible for the study of which 13 infants were excluded due to one parent refused, 12 other infants were started on TPN prior to obtaining informed consent.

Participant milestones

Participant milestones
Measure	Higher Infusion Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.	Standard Infusion Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
Overall Study STARTED	12	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Higher Infusion Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.	Standard Infusion Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
Overall Study Death	1	0
Overall Study Protocol Violation	2	0

Baseline Characteristics

Intravenous Fat Emulsions and Premature Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Infusion n=10 Participants Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.	Higher Infusion n=12 Participants Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 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
Age, Continuous	23.7 weeks STANDARD_DEVIATION 0.68 • n=5 Participants	24.33 weeks STANDARD_DEVIATION 1 • n=7 Participants	24 weeks STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: First 7 days of life

Population: This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater

Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.

Outcome measures

Outcome measures
Measure	Higher Infusion n=9 Participants Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.	Standard Infusion n=10 Participants Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl	9 participants	4 participants

SECONDARY outcome

Timeframe: First 2 weeks of life

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kamlesh Macwan

OSF Saint Francis Medical Center

Phone: 309-624-0611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place