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

iii Phone

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

iv Email

hshslam@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Lam, Hugh Simon Hung San

ii Address

iii Phone

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

iv Email

hshslam@cuhk.edu.hk

v Affiliation

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 preterm infants requiring long-term parenteral nutrition

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Preterm infant parenteral lipid study

12 Countries of Recruitment

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) gestation < 32 weeks; (ii) birth weight < 1500 g; (iii) serum conjugated bilirubin concentration > 34 mmol/L; (iv) informed parenteral consent 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).

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

Recruiting

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2009-08-21