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

July 16, 2022 updated by: Joanna Seliga-Siwecka, Princess Anna Mazowiecka Hospital, Warsaw, Poland

Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Renata Bokiniec, MD PhD
  • Phone Number: 004822596155
  • Email: rbokiniec@wp.pl

Study Locations

  • Poland
      • Warsaw, Poland, 00-315
      • Warsaw, Poland, 00-315
        • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 3 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
Patients will receive enteral feeding based on the practice of the leading physician.
EXPERIMENTAL: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Time Frame: up to two weeks life
Number of infants diagnosed with NEC.
up to two weeks life
Proportion of death
Time Frame: up to two weeks life
Death rate.
up to two weeks life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth
Time Frame: Number of infants with a significant median change from baseline within 12 months
centimeters per week.
Number of infants with a significant median change from baseline within 12 months
Proportion of number of interrupted feedings
Time Frame: final value within 4 weeks
per day.
final value within 4 weeks
Final median value of Vasoactive support
Time Frame: within 4 weeks
per day.
within 4 weeks
Median change from baseline of protein intake
Time Frame: within 4 weeks
grams/kg
within 4 weeks
Median change from baseline of caloric intake
Time Frame: within 4 weeks
kcal/kg/day
within 4 weeks
Proportion of final value of days required to reach full enteral feeding
Time Frame: within 4 weeks
days
within 4 weeks
Proportion of final value of days on mechanical ventilation
Time Frame: within 4 weeks
days
within 4 weeks
Proportion of final value of days required to regain birth weight
Time Frame: within 4 weeks
grams
within 4 weeks
Median change from baseline of breastfeeding of > 50%
Time Frame: within 12 months
per study arm
within 12 months
Proportion of culture proven late onset sepsis
Time Frame: 4 weeks
per group
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of final value of age at transfer
Time Frame: 4 weeks
months
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 10, 2022

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

October 31, 2021

First Posted (ACTUAL)

November 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 16, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIOFEED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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