Enteral Feeding in Infants With Duct Dependant Lesions.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-72
SponsorPrincess Anna Mazowiecka Hospital, Warsaw, Poland
About this 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.
Eligibility criteria
Qualifiers
Duct dependent congenital heart disease
Term infants
Parental/legal guardian consent
Disqualifiers
Potential contradictions to early central feeding
Feeding intolerance
Hemodynamic instability
Death
Trial design
Treatments tested in this trial
- enteral feeding as per predefined protocol
Treatment groups
384 Participants
are divided into 2 treatment groupsLocations
2Department of Neonatology and Neonatal Intensive Care Warsaw Medical University00-315, Warsaw Poland
Princess Anna Mazowiecka Hospital00-315, Warsaw Poland
Sponsors and collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Lead sponsor
Source ClinicalTrials.gov