Status:

UNKNOWN

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

Lead Sponsor:

Shanghai Jiao Tong University School of Medicine

Conditions:

Preterm Infant

Eligibility:

All Genders

1-28 years

Phase:

PHASE4

Brief 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 ...

Detailed 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 li...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2021

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT04277923

Start Date

February 1 2020

End Date

August 1 2021

Last Update

February 20 2020

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