Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00161

2 Trial Registration Date

2008-03-31

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department of Paediatrics, CUHK

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lam, Hugh Simon Hung San

ii Address

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

iii Phone

26322211

iv Email

hshslam@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Lam, Hugh Simon Hung San

ii Address

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

iii Phone

26322211

iv Email

hshslam@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomised, double-blind, controlled study of Omegaven for rescue treatment of parenteral nutrition-associated cholestasis (PNAC) in infants requiring long-term parenteral nutrition

10 Public Title

A randomised, double-blind, controlled study of Omegaven for rescue treatment of parenteral nutrition-associated cholestasis (PNAC) in infants requiring long-term parenteral nutrition

i Public Title in Chinese 研究名稱

探討腸道外營養液魚油(Omegaven)治療肝損傷的效果

11 Short Title (Optional)

Treatment infant parenteral lipid study

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-02-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Parenteral nutrition-associated cholestasis in infants

15 Intervention

i Types of intervention

Other

Please specify

parenteral lipid supplement

ii Description/ name of Intervention/article

Omegaven (fish oil-based parenteral lipid supplement)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

For as long as subject requires parenteral nutrition (may be 4 months or more)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Intralipid (soy-based parenteral lipid supplement)

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: (i) developed PNAC, defined as serum conjugated bilirubin concentration ≥ 34 mmol/L on routine weekly liver function assessment, in patients on parental nutrition
(ii) expected to receive at least two more weeks of parenteral nutrition
(iii) informed parental consent

ii Exclusion Criteria

(i) major congenital or lethal chromosomal abnormalities
(ii) multiorgan failure and imminent death
(iii) cholestatic jaundice secondary to other known causes e.g., congenital or acquired TORCH and syphillis infection; hepatitis B and C infection; biliary atresia and other lesions obstructing bile flow, both intrahepatic and extrahepatic

iii Age Minimum

0 days

iv Age Maximum

12 months

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-04-30

21 Target Sample Size

54

22 Recruitment Status

Complete

23 Primary Outcome

Reversal of PNAC over 4 months

24 Secondary Outcome

Infant growth; blood lipid profile; coagulation status; episodes of late-onset infection over 4 months.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-04-05

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000718

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2013-04-05