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Enteral Feeding in Infants With Duct Dependant Lesions. (CARDIOFEED)

Primary Purpose

Duct Dependent Lesions, Necrotising Enterocolitis, Death

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
enteral feeding as per predefined protocol
Sponsored by
Princess Anna Mazowiecka Hospital, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Duct Dependent Lesions focused on measuring congenital heart disease, nutrition, growth, newborn

Eligibility Criteria

1 Minute - 72 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Duct dependent congenital heart disease
  2. Term infants
  3. Parental/legal guardian consent

Exclusion criteria:

  1. Potential contradictions to early central feeding
  2. Feeding intolerance
  3. Hemodynamic instability
  4. Death
  5. > 50% formula based enteral feeding
  6. Birth weight less than 2500g

Sites / Locations

  • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
  • Princess Anna Mazowiecka Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Number of infants diagnosed with NEC.
Proportion of death
Death rate.

Secondary Outcome Measures

growth
centimeters per week.
Proportion of number of interrupted feedings
per day.
Final median value of Vasoactive support
per day.
Median change from baseline of protein intake
grams/kg
Median change from baseline of caloric intake
kcal/kg/day
Proportion of final value of days required to reach full enteral feeding
days
Proportion of final value of days on mechanical ventilation
days
Proportion of final value of days required to regain birth weight
grams
Median change from baseline of breastfeeding of > 50%
per study arm
Proportion of culture proven late onset sepsis
per group

Full Information

First Posted
October 31, 2021
Last Updated
July 16, 2022
Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05117164
Brief Title
Enteral Feeding in Infants With Duct Dependant Lesions.
Acronym
CARDIOFEED
Official Title
Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth
Keywords
congenital heart disease, nutrition, growth, newborn

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients will receive enteral feeding based on the practice of the leading physician.
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
enteral feeding as per predefined protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Description
Number of infants diagnosed with NEC.
Time Frame
up to two weeks life
Title
Proportion of death
Description
Death rate.
Time Frame
up to two weeks life
Secondary Outcome Measure Information:
Title
growth
Description
centimeters per week.
Time Frame
Number of infants with a significant median change from baseline within 12 months
Title
Proportion of number of interrupted feedings
Description
per day.
Time Frame
final value within 4 weeks
Title
Final median value of Vasoactive support
Description
per day.
Time Frame
within 4 weeks
Title
Median change from baseline of protein intake
Description
grams/kg
Time Frame
within 4 weeks
Title
Median change from baseline of caloric intake
Description
kcal/kg/day
Time Frame
within 4 weeks
Title
Proportion of final value of days required to reach full enteral feeding
Description
days
Time Frame
within 4 weeks
Title
Proportion of final value of days on mechanical ventilation
Description
days
Time Frame
within 4 weeks
Title
Proportion of final value of days required to regain birth weight
Description
grams
Time Frame
within 4 weeks
Title
Median change from baseline of breastfeeding of > 50%
Description
per study arm
Time Frame
within 12 months
Title
Proportion of culture proven late onset sepsis
Description
per group
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Proportion of final value of age at transfer
Description
months
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Duct dependent congenital heart disease Term infants Parental/legal guardian consent Exclusion criteria: Potential contradictions to early central feeding Feeding intolerance Hemodynamic instability Death > 50% formula based enteral feeding Birth weight less than 2500g
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Płotko, MD
Phone
004822596136
Email
plotko.ariel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Bokiniec, MD PhD
Phone
004822596155
Email
rbokiniec@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Bokiniec, MD PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joanna Seliga-Siwecka, MD PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ariel Płotko
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agata Wojcik-Sep
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Princess Anna Mazowiecka Hospital
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Seliga-Siwecka
Email
joanna.seliga@wum.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36158805
Citation
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.
Results Reference
derived

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Enteral Feeding in Infants With Duct Dependant Lesions.

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