Early Higher Intravenous Lipid Intake in VLBW Infants

NCT03594474 | Completed DMC

• 1 other identifier: REB17-2236
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Provision of high and early fat intake may help to reduce the amount of postnatal weight loss in Very Low Birth Weight Infants. It may also help utilize the high amount of protein that is currently recommended to these premature babies. Also, we expect babies who get this appropriate intake to regain their birth weight earlier than others who are on slow fat increase regimen.

Conditions

Very Low Birth Weight Infant

Keywords

intravenous fat emulsions; preterm infants

Outcome Measures

Primary Outcomes (1)

• The maximum percentage of weight loss

  (birth weight-lowest postnatal weight)/birth weight× 100).

  Until patient regains birth weight, on average within 14 days

Study Arms (2)

control group

NO INTERVENTION

Begins treatment with 0.5 g/kg per day of 20% Intravenous Lipid Emulsion (IVLE) after birth if the birth weight is less or equal 1000g or 1 g/kg per day if birth weight is more than 1000g. The IVLE dose in this group will be increased by 0.5 g/kg per day daily until reaching 3 g/kg per day.

experimental group

EXPERIMENTAL

The experimental group will begin treatment with 2 g/kg per day of 20% Intravenous Lipid Emulsion after birth. The dose of IVLE will be increased directly from 2 to 3 g/kg per day the next day in this group.

Other: Intravenous lipid emulsion

Interventions

Intravenous lipid emulsion OTHER

using higher dose of IV lipids after birth

Also known as: Intralipid

experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm infants born with birth weight \< 1500 g
• Appropriate for gestational age (AGA)
• Anticipated duration of PN for \>7 days

You may not qualify if:

• Infants with congenital anomalies
• Infants with suspected inborn errors of metabolism or family history of inborn error of metabolism
• Infants with suspected or confirmed biliary atresia
• Infants born small for gestational age (SGA)
• Confirmed early sepsis

Sponsors & Collaborators

• Belal Alshaikh: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (1)

• Alburaki W, Yusuf K, Dobry J, Sheinfeld R, Alshaikh B. High Early Parenteral Lipid in Very Preterm Infants: A Randomized-Controlled Trial. J Pediatr. 2021 Jan;228:16-23.e1. doi: 10.1016/j.jpeds.2020.08.024. Epub 2020 Aug 13.

  PMID: 32798567 DERIVED

MeSH Terms

Interventions

Fat Emulsions, Intravenous; soybean oil, phospholipid emulsion

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Belal Alshaikh, MD,MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 20, 2018
• Study Start: August 15, 2018
• Primary Completion: July 8, 2019
• Study Completion: October 19, 2019
• Last Updated: December 21, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)