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Enteral Feeding in Infants With Duct Dependant Lesions.
Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
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.
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.
Key Details
Gender
All
Age Range
1 Minute - 72 Hours
Study Type
INTERVENTIONAL
Enrollment
384
Start Date
2022-08-10
Completion Date
2026-12-31
Last Updated
2022-07-20
Healthy Volunteers
No
Interventions
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 (2)
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, Poland
Princess Anna Mazowiecka Hospital
Warsaw, Poland