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SAFETY AND EFFICACY OF A LIPID EMULSION CONTAINING A MIXTURE OF SOYBEAN OIL, MEDIUM-CHAIN TRIGLYCERIDES OLIVE OIL FISH OIL IN SURGICAL NEONATE RECEIVING PARENTERAL NUTRITION AT QUEEN SIRIKIT NATIONAL INSTITUTE OF CHILD HEALTH

SAFETY AND EFFICACY OF A LIPID EMULSION CONTAINING A MIXTURE OF SOYBEAN OIL, MEDIUM-CHAIN TRIGLYCERIDES OLIVE OIL FISH OIL IN SURGICAL NEONATE RECEIVING PARENTERAL NUTRITION AT QUEEN SIRIKIT NATIONAL INSTITUTE OF CHILD HEALTH

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20130313002
Enrollment
42
Registered
2013-03-13
Start date
2013-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Neonate with gastroschisis omphalocele and jejunoileal atresia Parenteral nutrition&#44

Interventions

start 0.5 g/kg/day = day I and increase step wise(by 0.5 g) up to 3.5 g/kg/day on day 7 &#45
until parenteral nutrition stop,start 0.5 g/kg/day = day I and increase step wise(by 0.5 g) up to 3.5 g/kg/day on day 7 &#45
until parenteral nutrition stop
Experimental Drug,Experimental Drug
SMOFlipid,Soybean lipid

Sponsors

CU. GRADUATE SCHOOL THESIS GR
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Neonates with gastroschisis, omphalocele , Jejunoileal atresia at QUEEN SIRIKIT NATIONAL INSTITUTE OF CHILD HEALTH (CHILDREN’S HOSPITAL) and will receive parenteral nutrition at least 7 days

Exclusion criteria

Exclusion criteria: 1. Severe congenital malformations 2. Congenital heart failure 3. Anuria due to circulation failure 4. Liver/hemolytic disease/ infectious hepatitis àªè¹ âäµÑºÍÑ¡àʺ A&#44;B&#44;C&#44;D &#44;G &#44;cytomegalovirus&#44;epstein&#45;Barr virus &#44; herpes simplex viruses&#44; toxoplasma gondii 5. Thrombocytopenia ;platelets <50 &times; 109/L 6. Oxygen saturation SO2 <80% longer than 2 hours 7. Severe acidosis 8. Application of catecholamines 9. Multiorgan failure 10. Hypoxic&#45;ischemic encephalopathy 11. Shock 12. Sepsis

Design outcomes

Primary

MeasureTime frame
Safety approximate 7&#45;14 days Blood samples for asessment of Liver Function Test &#44; GGT&#44;Triglyceride—

Secondary

MeasureTime frame
Efficacy approximate 7&#45;14 days Relative change in weight between day 0 and final (until parenteral nutrition stop)—

Countries

Thailand

Contacts

Public ContactSuntaree Rattana chueak

Queen Sirikit National Institute of Child Health

suntaree59@gmail.com66851182126

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026