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Enteral Feeding in Infants With Duct Dependant Lesions.

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Trial details

Who runs it
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Trial code
NCT05117164
Record updated
20 July 2022
Original description
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.Read full original descriptionShow less

Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.

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.

Inclusion: Duct dependent congenital heart disease; Term infants; Parental/legal guardian consent.

Exclusion: Potential contradictions to early central feeding; Feeding intolerance; Hemodynamic instability; Death; > 50% formula based enteral feeding; Birth weight less than 2500g.

ClinicalTrials.gov NCT05117164