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Enteral Feeding in Infants With Duct Dependant Lesions.

NCT05117164 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • Duct Dependent Lesions
  • Necrotising Enterocolitis
  • Death
  • Growth

Interventions

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.

Sponsors & Collaborators

  • Princess Anna Mazowiecka Hospital, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Renata Bokiniec, MD PhD · Medical University of Warsaw

  • Joanna Seliga-Siwecka, MD PhD · Medical University of Warsaw

  • Ariel Płotko · Medical University of Warsaw

  • Agata Wojcik-Sep · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05117164 on ClinicalTrials.gov