| Study name |
Preventing cholestasis using SMOFLipid®. |
| Methods |
Allocation: Randomised
Endpoint Classification: Efficacy study
Intervention model: Parallel assignment
Masking: Double blind (subject, investigator, outcomes assessor)
Primary purpose: Prevention |
| Participants |
Birth weight ≤ 1000 g
Admission to the neonatal ward in the first 24 hours of life
Informed consent and randomisation in the first five days of life |
| Interventions |
Experimental: SMOFLipid® (mixture of soy, fish, medium chain triglycerides, and olive oil); target dose: 3 g/kg/day
Comparator: Intralipid® (soy bean oil); target dose: 3g/kg/d |
| Outcomes |
Primary Outcome: parenteral nutrition‐associated cholestasis defined as two conjugated bilirubin > 1.5 mg/dl measurements on two consecutive occasions.
Secondary Outcome: The most important secondary outcome is neurodevelopment at 12 and 24 months of corrected age. |
| Starting date |
June 2012 |
| Contact information |
Study Director: Andreas Repa, MD, Medical University Vienna. |
| Notes |
None. |
