Enteral Feeding in Infants With Duct Dependant Lesions.
NCT ID: NCT05117164
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
384 participants
INTERVENTIONAL
2022-08-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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control group
Patients will receive enteral feeding based on the practice of the leading physician.
No interventions assigned to this group
intervention
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.
enteral feeding as per predefined protocol
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.
Interventions
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enteral feeding as per predefined protocol
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
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Inclusion Criteria
2. Term infants
3. Parental/legal guardian consent
Exclusion Criteria
2. Feeding intolerance
3. Hemodynamic instability
4. Death
5. \> 50% formula based enteral feeding
6. Birth weight less than 2500g
1 Minute
72 Hours
ALL
No
Sponsors
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Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Joanna Seliga-Siwecka
Principal investigator
Principal Investigators
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Renata Bokiniec, MD PhD
Role: STUDY_CHAIR
Medical University of Warsaw
Joanna Seliga-Siwecka, MD PhD
Role: STUDY_DIRECTOR
Medical University of Warsaw
Ariel Płotko
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Agata Wojcik-Sep
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, , Poland
Princess Anna Mazowiecka Hospital
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CARDIOFEED
Identifier Type: -
Identifier Source: org_study_id
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