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

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Not yet enrolling

Conditions: Death; Necrotising Enterocolitis; Duct Dependent Lesions; Growth

Treatments: Other: enteral feeding as per predefined protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05117164

CARDIOFEED

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: All

Ages: 1 minute to 72 hours old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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384 participants in 2 patient groups

control group

No Intervention group

Description:

Patients will receive enteral feeding based on the practice of the leading physician.

intervention

Experimental group

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.

Treatment:

Other: enteral feeding as per predefined protocol