Enteral Feeding in Infants With Duct Dependant Lesions.

Death Clinical Trial

— CARDIOFEED  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05117164
• Other study ID #: CARDIOFEED
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Death
• Enterocolitis
• Enterocolitis, Necrotizing
• Growth
• Necrotising Enterocolitis

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