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

ISRCTN	ISRCTN30436526
DOI	https://doi.org/10.1186/ISRCTN30436526
Protocol serial number	N/A
Sponsor	Khon Kaen University (Thailand)
Funder	Khon Kaen University (Thailand) - Faculty of medicine research grant

Submission date: 12/10/2010
Registration date: 25/11/2010
Last edited: 25/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ratchaneewan Sinitkul
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised double blind controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Fish-oil containing lipid emulsions can reduced parenteral nutrition induced cholestatic jaundice in premature infants.
Ethics approval(s)	The Khonkaen University Ethics committee for human research approved on the 8th of September 2010 (ref: HE531238)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/10/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Thailand

Study participating centre

Department of Pediatrics

Khon Kaen
40002
Thailand

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes