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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05117164
Other study ID # CARDIOFEED
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 10, 2022
Est. completion date December 31, 2026

Study information

Verified date July 2022
Source Princess Anna Mazowiecka Hospital, Warsaw, Poland
Contact Ariel Plotko, MD
Phone 004822596136
Email plotko.ariel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 384
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Minute to 72 Hours
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Poland Department of Neonatology and Neonatal Intensive Care Warsaw Medical University Warsaw
Poland Princess Anna Mazowiecka Hospital Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of final value of age at transfer months 4 weeks
Primary Proportion of final diagnosis of necrotizing enterocolitis (NEC). Number of infants diagnosed with NEC. up to two weeks life
Primary Proportion of death Death rate. up to two weeks life
Secondary growth centimeters per week. Number of infants with a significant median change from baseline within 12 months
Secondary Proportion of number of interrupted feedings per day. final value within 4 weeks
Secondary Final median value of Vasoactive support per day. within 4 weeks
Secondary Median change from baseline of protein intake grams/kg within 4 weeks
Secondary Median change from baseline of caloric intake kcal/kg/day within 4 weeks
Secondary Proportion of final value of days required to reach full enteral feeding days within 4 weeks
Secondary Proportion of final value of days on mechanical ventilation days within 4 weeks
Secondary Proportion of final value of days required to regain birth weight grams within 4 weeks
Secondary Median change from baseline of breastfeeding of > 50% per study arm within 12 months
Secondary Proportion of culture proven late onset sepsis per group 4 weeks
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