NCT01050660

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 28, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

3.4 years

First QC Date

December 23, 2009

Results QC Date

January 21, 2014

Last Update Submit

October 27, 2014

Conditions

Parenteral Nutrition-Associated Liver Disease

Keywords

Parenteral nutrition associated liver diseaseDirect bilirubinIntravenous fat emulsionVery low birth weight infantsPNAC

Outcome Measures

Primary Outcomes (1)

  • The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.

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

Secondary Outcomes (9)

  • Mortality Rate- Death Rate Before Discharge From the Hospital

    Discharge from the Newborn ICU

  • Incidence of Bronchopulmonary Dysplasia (BPD)

    36 weeks PMA or discharge home,whichever comes first

  • Incidence of Necrotizing Enterocolitis (NEC)

    At discharge from Newborn ICU

  • Incidence of Retinopathy of Prematurity (ROP)

    At discharge from Newborn ICU

  • Late Onset Sepsis

    At the discharge from Newborn ICU

  • +4 more secondary outcomes

Study Arms (2)

3 gm/kg/day intravenous lipid emulsion

ACTIVE COMPARATOR
Other: Intravenous fat emulsion

Intravenous Fat Emulsion-restricted

EXPERIMENTAL
Other: Restriction of intravenous fat emulsion to 1 gm/kg/d

Interventions

Intravenous fat emulsionOTHER

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.

3 gm/kg/day intravenous lipid emulsion
Restriction of intravenous fat emulsion to 1 gm/kg/dOTHER

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.

Intravenous Fat Emulsion-restricted

Eligibility Criteria

Age12 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants less than or equal to 29 weeks' gestation
  • Age less than 48 hours

You may not qualify if:

  • 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 \< 6.8 \> 2 hours)
  • Inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

Location

Related Publications (3)

  • Lee EJ, Simmer K, Gibson RA. Essential fatty acid deficiency in parenterally fed preterm infants. J Paediatr Child Health. 1993 Feb;29(1):51-5. doi: 10.1111/j.1440-1754.1993.tb00440.x.

    PMID: 8461181BACKGROUND

  • Colomb V, Jobert-Giraud A, Lacaille F, Goulet O, Fournet JC, Ricour C. Role of lipid emulsions in cholestasis associated with long-term parenteral nutrition in children. JPEN J Parenter Enteral Nutr. 2000 Nov-Dec;24(6):345-50. doi: 10.1177/0148607100024006345.

    PMID: 11071594BACKGROUND

  • Boyd GW. An investigation of the prolonged pressor response to renin in the nephrectomized rat. Clin Sci Mol Med Suppl. 1976 Dec;3:151s-153s. doi: 10.1042/cs051151s.

    PMID: 1071594BACKGROUND

MeSH Terms

Interventions

Fat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

EmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Dr. Orly Levit
Organization
Yale University
orly.levit@yale.edu
203-688-2320

Study Officials

  • Richard A Ehrenkranz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

December 23, 2009

First Posted

January 15, 2010

Study Start

June 1, 2009

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

October 28, 2014

Results First Posted

October 28, 2014

Record last verified: 2014-10

Locations

US(1)