Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants

Preterm Infant Clinical Trial

Official title:

Effects of Medium and Long Chain Fat Emulsions and SMOF Fat Emulsions on PNALD and Oxidative Stress in Premature Infants: a Randomized, Double-blind Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277923
• Other study ID #: PNALD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ying Wang, Phd
• Phone: 8613611884226
• Email: wangying_ssmu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Drug:
• SMOFlipid
the lipid of all-in-one is less than 4g/kg.d
• Lipofundin
the lipid of all-in-one is less than 4g/kg.d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of fatty acids spectrum	cholic acid, deoxycholic acid,chenodeoxycholic acid,ursodeoxycholic acid and lithocholic acid in mol%,et al.	change from baseline in fatty acids spectrum at 7 days and 14 days
Primary	Change of liver function indexes	liver enzyme in u/L	change from baseline in liver function indexes at 7 days and 14 days
Primary	Change of bilirubin indexes	bilirubin in µmol/L	change from baseline in bilirubin indexes at 7 days and 14 days
Secondary	Change of superoxidase dismutase	superoxidase dismutase in u/L	change from baseline in superoxidase dismutase at 7 days and 14 days
Secondary	Change of malondialdehyde	malondialdehyde in nmol/ml	change from baseline in malondialdehyde at 7 days and 14 days
Secondary	Change of inflammatory factors	IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-a in pg/ml	change from baseline in fatty acid at 7 days and 14 days