Enteral Feeding in Infants With Duct Dependant Lesions.

Not Applicable

Not yet recruiting

• Conditions: Death; Growth; Necrotising Enterocolitis; Duct Dependent Lesions
• Interventions: Other: enteral feeding as per predefined protocol

• Registration Number: NCT05117164
• Lead Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-10-31
• Study First Posted: 2021-11-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-20
• Study Start: 2022-08-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of number of interrupted feedings	final value within 4 weeks	per day.
Proportion of final value of days required to reach full enteral feeding	within 4 weeks	days
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
growth	Number of infants with a significant median change from baseline within 12 months	centimeters per week.
Final median value of Vasoactive support	within 4 weeks	per day.
Median change from baseline of protein intake	within 4 weeks	grams/kg

Trial Locations

Locations (2)

Princess Anna Mazowiecka Hospital; 🇵🇱 Warsaw, Poland

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University; 🇵🇱 Warsaw, Poland