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

Phase 2

• Conditions: eonate with gastroschisis omphalocele and jejunoileal atresia; Parenteral nutrition, Liver function, Fish oil , Lipid

• Registration Number: TCTR20130313002
• Lead Sponsor: CU. GRADUATE SCHOOL THESIS GR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-13
• Study Completion: 2013-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 42

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety approximate 7-14 days Blood samples for asessment of Liver Function Test , GGT,Triglyceride

Secondary Outcome Measures

Name	Time	Method
Efficacy approximate 7-14 days Relative change in weight between day 0 and final (until parenteral nutrition stop)