Duct Dependent LesionsCARDIOFEEDNCT05117164
Enteral Feeding in Infants With Duct Dependant Lesions.
A study testing enteral feeding as per predefined protocol in people with Duct Dependent Lesions and Necrotising Enterocolitis, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hours
- Conditions the study is for
- Duct Dependent Lesions, Necrotising Enterocolitis, Death
- What is being tested?
- enteral feeding as per predefined protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesPoland
- Study dates
- 10 Aug 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Duct dependent congenital heart disease
- Term infants
- Parental/legal guardian consent
Who cannot join
- Potential contradictions to early central feeding
- Feeding intolerance
- Hemodynamic instability
- Death
- > 50% formula based enteral feeding
- Birth weight less than 2500g
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
Princess Anna Mazowiecka Hospital
Warsaw, 00-315
Joanna Seliga-Siwecka, joanna.seliga@wum.edu.pl
About this study
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.
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.
- Conditions
- Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth
- Being tested
- enteral feeding as per predefined protocol
- Keywords
- congenital heart disease, nutrition, growth, newborn
- Medical subject headings
- Enterocolitis, Necrotizing, Death, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral feeding as per predefined protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients will receive enteral feeding based on the practice of the leading physician. |
| intervention | Experimental | 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. Receives: Other: enteral feeding as per predefined protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Number of infants diagnosed with NEC.
Measured: up to two weeks life
Proportion of death
Death rate.
Measured: up to two weeks life
Secondary outcomes (10)
growth
centimeters per week.
Measured: Number of infants with a significant median change from baseline within 12 months
Proportion of number of interrupted feedings
per day.
Measured: final value within 4 weeks
Final median value of Vasoactive support
per day.
Measured: within 4 weeks
Median change from baseline of protein intake
grams/kg
Measured: within 4 weeks
Median change from baseline of caloric intake
kcal/kg/day
Measured: within 4 weeks
Proportion of final value of days required to reach full enteral feeding
days
Measured: within 4 weeks
Proportion of final value of days on mechanical ventilation
days
Measured: within 4 weeks
Proportion of final value of days required to regain birth weight
grams
Measured: within 4 weeks
Median change from baseline of breastfeeding of > 50%
per study arm
Measured: within 12 months
Proportion of culture proven late onset sepsis
per group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start10 Aug 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duct Dependent LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Seliga-Siwecka, Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Investigators
- Renata Bokiniec, MD PhD, Study chair, Medical University of WarsawJoanna Seliga-Siwecka, MD PhD, Study director, Medical University of WarsawAriel Płotko, Principal investigator, Medical University of WarsawAgata Wojcik-Sep, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117164
- Sponsor's protocol ID
- CARDIOFEED
- Acronym
- CARDIOFEED
- Status last verified
- Jul 2022
- First submitted
- 31 Oct 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36158805
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05117164
- Acronym / sponsor ID
- CARDIOFEED / CARDIOFEED
- Conditions
- Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth
- Keywords
- congenital heart disease, nutrition, growth, newborn
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 10 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients will receive enteral feeding based on the practice of the leading physician. |
| intervention | Experimental | Other: enteral feeding as per predefined protocolInfants 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. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Duct dependent congenital heart disease
- Term infants
- Parental/legal guardian consent
Key exclusion criteria (6 listed)
- Potential contradictions to early central feeding
- Feeding intolerance
- Hemodynamic instability
- Death
- > 50% formula based enteral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral feeding as per predefined protocolInfants 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 | intervention |
Primary outcome
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Time frame: up to two weeks life
Number of infants diagnosed with NEC.
Proportion of death
Time frame: up to two weeks life
Death rate.
10 secondary outcomes
growth
Time frame: 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
Final median value of Vasoactive support
Time frame: within 4 weeks
Median change from baseline of protein intake
Time frame: within 4 weeks
Median change from baseline of caloric intake
Time frame: within 4 weeks
Proportion of final value of days required to reach full enteral feeding
Time frame: within 4 weeks
Proportion of final value of days on mechanical ventilation
Time frame: within 4 weeks
Proportion of final value of days required to regain birth weight
Time frame: within 4 weeks
Median change from baseline of breastfeeding of > 50%
Time frame: within 12 months
Proportion of culture proven late onset sepsis
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 36158805Seliga-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renata Bokiniec, MD PhD study chair
Medical University of Warsaw
Joanna Seliga-Siwecka, MD PhD study director
Medical University of Warsaw
Ariel Płotko principal investigator
Medical University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral feeding as per predefined protocol in people with Duct Dependent Lesions and Necrotising Enterocolitis, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel Płotko, MD (004822596136, plotko.ariel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of final diagnosis of necrotizing enterocolitis (NEC). (time frame: up to two weeks life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.