Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00160

2 Trial Registration Date

2008-03-31

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Department of Paediatrics, CUHK

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

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

Hong Kong, China

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

Hong Kong, China

9 Official Scientific Title of the Study

A randomized, double-blind, controlled study of Omegaven for prophylaxis against parenteral nutrition-associated cholestasis (PNAC) in infants requiring prolonged parenteral nutrition

10 Public Title

A randomized, double-blind, controlled study of Omegaven for prophylaxis against parenteral nutrition-associated cholestasis (PNAC) in infants requiring prolonged parenteral nutrition

i Public Title in Chinese 研究名稱

探討魚油(Omegaven)預防腸道外營養導致肝損傷的效果

11 Short Title (Optional)

Prevention of PNAC by omegaven

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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2007.462-T

14 Medical Condition Being Studied

Parenteral nutrition-associated cholestasis (PNAC)

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

10% Omegaven

iv Dosage of the intervention

1.5 g/kg/day

v Duration of the intervention

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

vi Frequency of the intervention

continuous intravenous infusion

16 Comparative Treatments

i Description/ name of comparative treatments

Intralipid (soy-based parenteral lipid supplement)

ii Dosage form of the comparative treatments

10% Intralipid

iii Dosage of the comparative treatments

1.5 g/kg/day

iv Duration of the comparative treatments

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

v Frequency of the comparative treatments

continuous intravenous infusion

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: (i) newborn infants without PNAC at the time of randomization; (ii) anatomical/functional short bowel syndrome or expected to be nil by mouth for > 4 weeks; (iii) informed parenteral consent

ii Exclusion Criteria

Exclusion criteria: (i) major congenital or lethal chromosomal abnormalities; (ii) multiorgan failure and imminent death; (iii) cholestatic jaundice secondary to known cause other than parenteral nutrition associated cholestasis (PNAC).

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

Randomised controlled trial

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

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-04-30

21 Target Sample Size

26

22 Recruitment Status

Recruiting

23 Primary Outcome

Development 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

2020-04-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-08000717

28 Date of Registration in Primary Registry

2010-05-04

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Trial History Detail on 2016-09-15