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

NCT04277923 | Unknown Phase 4 DMC

• 1 other identifier: PNALD
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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 (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.

Conditions

Preterm Infant

Keywords

parenteral nutrition; lipid emulsion; SMOF; PNALD; oxidative stress

Outcome Measures

Primary Outcomes (2)

• Change of liver function indexes

  liver enzyme in u/L

  change from baseline in liver function indexes at 7 days and 14 days

• Change of bilirubin indexes

  bilirubin in μmol/L

  change from baseline in bilirubin indexes at 7 days and 14 days

Secondary Outcomes (3)

• Change of superoxidase dismutase

  change from baseline in superoxidase dismutase at 7 days and 14 days

• Change of malondialdehyde

  change from baseline in malondialdehyde at 7 days and 14 days

• Change of inflammatory factors

  change from baseline in fatty acid at 7 days and 14 days

Other Outcomes (1)

• Change of fatty acids spectrum

  change from baseline in fatty acids spectrum at 7 days and 14 days

Study Arms (2)

SMOF lipid emulsion

EXPERIMENTAL

the SMOF lipid emulsion is SMOFlipid.

Drug: SMOFlipid

MCT/LCT lipid emulsion

EXPERIMENTAL

the MCT/LCT lipid emulsion is Lipofundin.

Drug: Lipofundin

Interventions

SMOFlipid DRUG

the lipid of all-in-one is less than 4g/kg.d

SMOF lipid emulsion

Lipofundin DRUG

the lipid of all-in-one is less than 4g/kg.d

MCT/LCT lipid emulsion

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Premature Birth; Hyperphagia

Interventions

SMOFlipid; Lipofundin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Wang, Phd

  Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang, Phd

CONTACT

8613611884226; wangying_ssmu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: February 20, 2020
• Study Start: February 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02