Condition category
Neonatal Diseases
Date applied
12/10/2010
Date assigned
25/11/2010
Last edited
25/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ratchaneewan Sinitkul

ORCID ID

Contact details

Department of Pediatrics
Faculty of Medicine
123 Mitarparp Road
Amphoe Muang
Khon Kaen
40002
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of soybean oil-based versus fish-oil containing lipid emulsions on parenteral nutrition induced cholestatic jaundice in premature infants: a randomised controlled study

Acronym

Study hypothesis

Fish-oil containing lipid emulsions can reduced parenteral nutrition induced cholestatic jaundice in premature infants.

Ethics approval

The Khonkaen University Ethics committee for human research approved on the 8th of September 2010 (ref: HE531238)

Study design

Randomised double blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Parenteral nutrition induced cholestatic jaundice in premature infants

Intervention

1. Control group : Patients were administered parenteral nutrition with a soybean oil-based supplement (Intralipid)
2. Study group : Patients were administered parenteral nutrition with fish-oil containing lipid emulsions (SMOF)
Patients in both groups received fat 0.5-3.5 gm/kg/day daily for 2 weeks. Parenteral nutrition was administered until full feeding was achieved.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total bilirubin and direct bilirubin.
All outcomes will be assessed at baseline and at 2 weeks after start parenteral nutrition and then follow up weekly until stop parenteral nutrition.

Secondary outcome measures

1. Alanine Aminotransferase (ALT)
2. Aspartate Aminotransferase (AST)
3. Alkaline Phosphatase (ALP)
All outcomes will be assessed at baseline and at 2 weeks after start parenteral nutrition and then follow up weekly until stop parenteral nutrition.

Overall trial start date

01/10/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preterm < 34 weeks of gestational age who admitted to NICU and sick newborn ward at Srinagarind hospital
2. Post natal age not more than 1 month
3. Meet indication for parenteral nutrition
4. Parent permitted to be the participant

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

60 participants

Participant exclusion criteria

1. Risk for bleeding tendency: Platelet less than 60,000 /mm3, coagulopathy
2. Risk for hepatic dysfunction: severe birth asphyxia
3. Fatal chromosome abnormality (Trisomy 13, 15, 18)
5. Direct bilirubin more than 2 mg/dl before start experiment

Recruitment start date

01/10/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Pediatrics
Khon Kaen
40002
Thailand

Sponsor information

Organisation

Khon Kaen University (Thailand)

Sponsor details

Research Affairs
Faculty of Medicine
123 Mitarparp Road
Amphoe Muang
Khon Kaen
40002
Thailand

Sponsor type

University/education

Website

http://www.md.kku.ac.th/research/index.php?option=com_contact&Itemid=3

Funders

Funder type

University/education

Funder name

Khon Kaen University (Thailand) - Faculty of medicine research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes