Enteral Feeding in Infants With Duct Dependant Lesions.
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.
1 other identifier
interventional
384
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 20, 2022
July 1, 2022
3.4 years
October 31, 2021
July 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (10)
growth
Number of infants with a significant median change from baseline within 12 months
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
- +5 more secondary outcomes
Other Outcomes (1)
Proportion of final value of age at transfer
4 weeks
Study Arms (2)
control group
NO INTERVENTIONPatients will receive enteral feeding based on the practice of the leading physician.
intervention
EXPERIMENTALInfants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Duct dependent congenital heart disease
- Term infants
- Parental/legal guardian consent
You may not qualify if:
- Potential contradictions to early central feeding
- Feeding intolerance
- Hemodynamic instability
- Death
- \> 50% formula based enteral feeding
- Birth weight less than 2500g
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315, Poland
Princess Anna Mazowiecka Hospital
Warsaw, 00-315, Poland
Related Publications (1)
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.
PMID: 36158805DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Renata Bokiniec, MD PhD
Medical University of Warsaw
- STUDY DIRECTOR
Joanna Seliga-Siwecka, MD PhD
Medical University of Warsaw
- PRINCIPAL INVESTIGATOR
Ariel Płotko
Medical University of Warsaw
- PRINCIPAL INVESTIGATOR
Agata Wojcik-Sep
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 31, 2021
First Posted
November 11, 2021
Study Start
August 10, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
July 20, 2022
Record last verified: 2022-07