Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants
الكلمات الدالة
نبذة مختصرة
وصف
For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution.
Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress.
Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.
تواريخ
| آخر التحقق: | 01/31/2020 |
| تم الإرسال لأول مرة: | 01/05/2020 |
| تم إرسال التسجيل المقدر: | 02/18/2020 |
| أول نشر: | 02/19/2020 |
| تم إرسال آخر تحديث: | 02/18/2020 |
| آخر تحديث تم نشره: | 02/19/2020 |
| تاريخ بدء الدراسة الفعلي: | 01/31/2020 |
| تاريخ الإنجاز الأساسي المقدر: | 07/31/2021 |
| التاريخ المتوقع لانتهاء الدراسة: | 07/31/2021 |
حالة أو مرض
التدخل / العلاج
Drug: SMOF lipid emulsion
Drug: MCT/LCT lipid emulsion
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: SMOF lipid emulsion the SMOF lipid emulsion is SMOFlipid. | Drug: SMOF lipid emulsion the lipid of all-in-one is less than 4g/kg.d |
| Experimental: MCT/LCT lipid emulsion the MCT/LCT lipid emulsion is Lipofundin. | Drug: MCT/LCT lipid emulsion the lipid of all-in-one is less than 4g/kg.d |
معايير الأهلية
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | Inclusion Criteria: - Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth - No contraindications to parenteral nutrition - Expected PN support for 14 days or more - Parents or guardians agree Exclusion Criteria: - Parenteral nutrition support was provided prior to enrollment - EN calorie for 10% or more - Congenital intestinal structural/functional abnormalities - Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract - Congenital or acquired immunodeficiency - Complex congenital heart disease |
النتيجة
مقاييس النتائج الأولية
1. Change of liver function indexes [change from baseline in liver function indexes at 7 days and 14 days]
2. Change of bilirubin indexes [change from baseline in bilirubin indexes at 7 days and 14 days]
مقاييس النتائج الثانوية
1. Change of superoxidase dismutase [change from baseline in superoxidase dismutase at 7 days and 14 days]
2. Change of malondialdehyde [change from baseline in malondialdehyde at 7 days and 14 days]
3. Change of inflammatory factors [change from baseline in fatty acid at 7 days and 14 days]
تدابير النتائج الأخرى
1. Change of fatty acids spectrum [change from baseline in fatty acids spectrum at 7 days and 14 days]
