Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
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|ClinicalTrials.gov Identifier: NCT01050660|
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : October 28, 2014
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Parenteral Nutrition-Associated Liver Disease||Other: Intravenous fat emulsion Other: Restriction of intravenous fat emulsion to 1 gm/kg/d||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||January 2013|
|Active Comparator: 3 gm/kg/day intravenous lipid emulsion||
Other: 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.
|Experimental: Intravenous Fat Emulsion-restricted||
Other: 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. [ Time Frame: 28 days of age or when full enteral nutrition is acheived, whichever is longer ]
- Mortality Rate- Death Rate Before Discharge From the Hospital [ Time Frame: Discharge from the Newborn ICU ]
- Incidence of Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks PMA or discharge home,whichever comes first ]
- Incidence of Necrotizing Enterocolitis (NEC) [ Time Frame: At discharge from Newborn ICU ]
- Incidence of Retinopathy of Prematurity (ROP) [ Time Frame: At discharge from Newborn ICU ]
- Late Onset Sepsis [ Time Frame: At the discharge from Newborn ICU ]Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.
- Length of Stay [ Time Frame: At discharge from Newborn ICU/death ]Defines time to discharge or death.
- Anthropometric Measurements(Body Weight) [ Time Frame: At age of 28 days and at discharge ]Change in body weight measurement reported in g/week
- Anthropometric Measurements(Length) [ Time Frame: At age of 28 days and at discharge ]Change in body length measurement reported in cm/week
- Anthropometric Measurements(Head Circumference) [ Time Frame: At age of 28 days and at discharge ]Change in head circumference measurement reported in cm/week
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050660
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520-8064|
|Principal Investigator:||Richard A Ehrenkranz, MD||Yale University|