CARDIOFEED
Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.
Sponsor study identifier
interventional
384
1 country
2
Study Start
August 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2021
Actual (reported)November 11, 2021
Actual (reported)August 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Number of infants diagnosed with NEC.
up to two weeks life
Proportion of death
Death rate.
up to two weeks life
growth
Number of infants with a significant median change from baseline within 12 months
Patients will receive enteral feeding based on the practice of the leading physician.
Infants will receive enteral feeding based on the following protocol. Enteral nutrition Minimal enteral nutrition (MEN) will begin within 72 hours life at 10 to 20. mL/kg/day, via bolus gravity breast milk/donor human milk. MEN will not be included in the caloric goals. Advancements in feeding will be set at 20-30 mL/kg/day, but not more than 10ml per feeding portion to reach a goal of 150ml/kg/day, but not than 120ml/kg/day cases of fluid restriction). The goal will be to reach an overall daily caloric intake of minimum 100kcal/kg/d.
Infants will receive enteral feeding based on the following protocol. Enteral nutrition Minimal enteral nutrition (MEN) will begin within 72 hours life at 10 to 20. mL/kg/day, via bolus gravity breast milk/donor human milk. MEN will not be included in the caloric goals. Advancements in feeding will be set at 20-30 mL/kg/day, but not more than 10ml per feeding portion to reach a goal of 150ml/kg/day, but not than 120ml/kg/day cases of fluid restriction). The goal will be to reach an overall daily caloric intake of minimum 100kcal/kg/d.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315, Poland
Princess Anna Mazowiecka Hospital
Warsaw, 00-315, Poland
Seliga-Siwecka J, Plotko A, Wojcik-Sep A, Bokiniec R, Latka-Grot J, Zuk M, Furmanczyk K, Zielinski W, Chrzanowska M. Effect of standardized vs. local preoperative enteral feeding practice on the incidence of NEC in infants with duct dependent lesions: Protocol for a randomized control trial. Front Cardiovasc Med. 2022 Sep 8;9:893764. doi: 10.3389/fcvm.2022.893764. eCollection 2022.
Renata Bokiniec, MD PhD
Medical University of Warsaw
Joanna Seliga-Siwecka, MD PhD
Medical University of Warsaw
Ariel Płotko
Medical University of Warsaw
Agata Wojcik-Sep
Medical University of Warsaw
First Submitted
October 31, 2021
First Posted
November 11, 2021
Study Start
August 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Proportion of number of interrupted feedings
final value within 4 weeks
Final median value of Vasoactive support
within 4 weeks
Median change from baseline of protein intake
within 4 weeks
Median change from baseline of caloric intake
within 4 weeks
Proportion of final value of age at transfer
4 weeks
Contact the study team to confirm eligibility.
December 31, 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 20, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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