N/A
N=136
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
Parenteral Nutrition-Associated Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01050660 ↗Enrolled (actual)
136
Serious AEs
8.1%
Results posted
Oct 2014
Primary outcome: Primary: The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. — 39; 45 participants who developed Cholestasis
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intravenous fat emulsion (Other); Restriction of intravenous fat emulsion to 1 gm/kg/d (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. |
39; 45 | — |
| SECONDARY Mortality Rate- Death Rate Before Discharge From the Hospital |
5; 6 | — |
| SECONDARY Incidence of Bronchopulmonary Dysplasia (BPD) |
27; 26 | — |
| SECONDARY Incidence of Necrotizing Enterocolitis (NEC) |
8; 11 | — |
| SECONDARY Incidence of Retinopathy of Prematurity (ROP) |
7; 9 | — |
| SECONDARY Late Onset Sepsis |
3; 5 | — |
| SECONDARY Length of Stay |
81.5; 87 | — |
| SECONDARY Anthropometric Measurements(Body Weight) |
66.6; 62.9 | — |
| SECONDARY Anthropometric Measurements(Length) |
0.8; 0.9 | — |
| SECONDARY Anthropometric Measurements(Head Circumference) |
0.5; 0.6 | — |
Summary
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
Eligibility Criteria
Inclusion Criteria
- Preterm infants less than or equal to 29 weeks' gestation
- Age less than 48 hours
Exclusion Criteria
- Congenital intrauterine infection, known to be associated with liver involvement and cholestasis
- Known structural liver abnormalities that are associated with cholestasis
- Known genetic disorders: trisomy 21, trisomy 13 and trisomy 18
- Inborn errors of metabolism
- Infants meeting the criteria for terminal illness (eg, pH 2 hours)
- Inability to obtain informed consent
Data sourced from ClinicalTrials.gov (NCT01050660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.