Enteral Feeding in Infants With Duct Dependant Lesions.

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05117164

Acronym

CARDIOFEED

Enrollment

384

Registered

2021-11-11

Start date

2022-08-10

Completion date

2026-12-31

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Duct Dependent Lesions, Growth, Necrotising Enterocolitis

Keywords

congenital heart disease, nutrition, growth, newborn

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.

Interventions

OTHERenteral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 72 Hours

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Proportion of final value of age at transfer	4 weeks	months

Countries

Poland

Contacts

Primary ContactAriel Płotko, MD

plotko.ariel@gmail.com004822596136

Backup ContactRenata Bokiniec, MD PhD

rbokiniec@wp.pl004822596155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026