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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30436526
Enrollment
60
Registered
2010-11-25
Start date
2010-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral nutrition induced cholestatic jaundice in premature infants Neonatal Diseases Neonatal jaundice from other and unspecified causes

Interventions

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 cont

Sponsors

Khon Kaen University (Thailand)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026