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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Pediatrics
Faculty of Medicine
123 Mitarparp Road
Amphoe Muang
Khon Kaen
40002
Thailand
Study information
| Study design | Randomised double blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/10/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 60 participants |
| 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
40002
Thailand
Sponsor information
Khon Kaen University (Thailand)
University/education
University/education
Research Affairs
Faculty of Medicine
123 Mitarparp Road
Amphoe Muang
Khon Kaen
40002
Thailand
| Website | http://www.md.kku.ac.th/research/index.php?option=com_contact&Itemid=3 |
|---|---|
"ROR" |
https://ror.org/03cq4gr50 |
Funders
Funder type
University/education
Khon Kaen University (Thailand) - Faculty of medicine research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
