Clinical Trial

Enteral Feeding in Infants With Duct Dependant Lesions.

Study acronym: CARDIOFEED
Not Yet Recruiting
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Record status
This record was last updated July 20, 2022 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and/or death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-10-31; most recent amendment 2022-07-16.
Trial Details
NCT Number NCT05117164
Lead Sponsor Princess Anna Mazowiecka Hospital, Warsaw, Poland
Conditions Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth
Enrollment 384 participants
Start Date 2022-08-10
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2022-07-20