Trial Outcomes & Findings for Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates (NCT NCT01050660)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

136 participants

Primary outcome timeframe

28 days of age or when full enteral nutrition is acheived, whichever is longer

Results posted on

2014-10-28

Participant Flow

Bewtween May 2009 -November 2012- infants born and admitted to NICU were enrolled.

Participant milestones

Participant milestones
Measure	3 gm/kg/Day Intravenous Lipid Emulsion Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Overall Study STARTED	67	69
Overall Study COMPLETED	67	69
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	67 Participants n=93 Participants	69 Participants n=4 Participants	136 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	23 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	46 Participants n=4 Participants	87 Participants n=27 Participants
Region of Enrollment United States	67 participants n=93 Participants	69 participants n=4 Participants	136 participants n=27 Participants
Gestational age at enrollement	26.4 weeks STANDARD_DEVIATION 1.8 • n=93 Participants	26.6 weeks STANDARD_DEVIATION 1.8 • n=4 Participants	26.5 weeks STANDARD_DEVIATION 1.8 • n=27 Participants

PRIMARY outcome

Timeframe: 28 days of age or when full enteral nutrition is acheived, whichever is longer

Population: Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%. Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.	39 participants who developed Cholestasis	45 participants who developed Cholestasis

SECONDARY outcome

Timeframe: Discharge from the Newborn ICU

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Mortality Rate- Death Rate Before Discharge From the Hospital	5 participants	6 participants

SECONDARY outcome

Timeframe: 36 weeks PMA or discharge home,whichever comes first

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Incidence of Bronchopulmonary Dysplasia (BPD)	27 participants who developed BPD	26 participants who developed BPD

SECONDARY outcome

Timeframe: At discharge from Newborn ICU

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Incidence of Necrotizing Enterocolitis (NEC)	8 participants who developed NEC	11 participants who developed NEC

SECONDARY outcome

Timeframe: At discharge from Newborn ICU

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Incidence of Retinopathy of Prematurity (ROP)	7 participants who developed ROP	9 participants who developed ROP

SECONDARY outcome

Timeframe: At the discharge from Newborn ICU

Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Late Onset Sepsis	3 participants who developed LOS	5 participants who developed LOS

SECONDARY outcome

Timeframe: At discharge from Newborn ICU/death

Defines time to discharge or death.

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Length of Stay	81.5 Days Interval 64.3 to 108.8	87 Days Interval 66.5 to 110.8

SECONDARY outcome

Timeframe: At age of 28 days and at discharge

Change in body weight measurement reported in g/week

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Anthropometric Measurements(Body Weight)	66.6 g/week Standard Deviation 34	62.9 g/week Standard Deviation 39

SECONDARY outcome

Timeframe: At age of 28 days and at discharge

Change in body length measurement reported in cm/week

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Anthropometric Measurements(Length)	0.8 cm/week Standard Deviation 0.5	0.9 cm/week Standard Deviation 0.5

SECONDARY outcome

Timeframe: At age of 28 days and at discharge

Change in head circumference measurement reported in cm/week

Outcome measures

Outcome measures
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 Participants Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 Participants Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
Anthropometric Measurements(Head Circumference)	0.5 cm/week Standard Deviation 0.3	0.6 cm/week Standard Deviation 0.3

Adverse Events

3 gm/kg/Day Intravenous Lipid Emulsion

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Fat Emulsion-restricted

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	3 gm/kg/Day Intravenous Lipid Emulsion n=67 participants at risk Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.	Intravenous Fat Emulsion-restricted n=69 participants at risk Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
General disorders Mortality prior to discharge	7.5% 5/67 • Number of events 5	8.7% 6/69 • Number of events 6

Other adverse events

Adverse event data not reported

Additional Information

Dr. Orly Levit

Yale University

Phone: 203-688-2320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place