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Not yet recruiting NCT05117164

Enteral Feeding in Infants With Duct Dependant Lesions.

No phase Interventional Duct Dependent Lesions Necrotising Enterocolitis Death Growth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: enteral feeding as per predefined protocol.
Who it may be relevant to
Registry conditions: Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth. Basic parameters: 1 Minute — 72 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

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 da

Primary outcome measures

  • Proportion of final diagnosis of necrotizing enterocolitis (NEC). [Time frame: up to two weeks life]
  • Proportion of death [Time frame: up to two weeks life]
Secondary outcome measures (10)
  • growth [Time frame: Number of infants with a significant median change from baseline within 12 months]
  • Proportion of number of interrupted feedings [Time frame: final value within 4 weeks]
  • Final median value of Vasoactive support [Time frame: within 4 weeks]
  • Median change from baseline of protein intake [Time frame: within 4 weeks]
  • Median change from baseline of caloric intake [Time frame: within 4 weeks]
  • Proportion of final value of days required to reach full enteral feeding [Time frame: within 4 weeks]
  • Proportion of final value of days on mechanical ventilation [Time frame: within 4 weeks]
  • Proportion of final value of days required to regain birth weight [Time frame: within 4 weeks]
  • Median change from baseline of breastfeeding of > 50% [Time frame: within 12 months]
  • Proportion of culture proven late onset sepsis [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • Duct dependent congenital heart disease
  • Term infants
  • Parental/legal guardian consent

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Poland · 2 centers
  • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University — Warsaw
  • Princess Anna Mazowiecka Hospital — Warsaw

Publications

  • Seliga-Siwecka J, Plotko A, Wojcik-Sep A, Bokiniec R, Latka-Grot J, Zuk M, Furmanczyk K, Zielinski W, Chrzanowska M. Effect of standardized vs. local preoperative enteral feeding practice on the incidence of NEC in infants with duct dependent lesions: Protocol for a randomized control trial. Front Cardiovasc Med. 2022 Sep 8;9:893764. doi: 10.3389/fcvm.2022.893764. eCollection 2022. PMID 36158805

Identifiers

NCT: NCT05117164 · CARDIOFEED

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗