Enteral Feeding in Infants With Duct Dependant Lesions.

ConditionsDuct Dependent Lesions Necrotising Enterocolitis Death Growth

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

enteral feeding as per predefined protocol
Other intervention
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.

Treatment groups

384 Participants

are divided into 2 treatment groups

Group A: control groupNo intervention 0 interventions

Group B: interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Proportion of final diagnosis of necrotizing enterocolitis (NEC).

Number of infants diagnosed with NEC.

Time frame

up to two weeks life

Proportion of death

Death rate.

Time frame

up to two weeks life

Secondary outcomes

growth

centimeters per week.

Time frame

Number of infants with a significant median change from baseline within 12 months

Proportion of number of interrupted feedings

per day.

Time frame

final value within 4 weeks

Final median value of Vasoactive support

per day.

Time frame

within 4 weeks

Median change from baseline of protein intake

grams/kg

Time frame

within 4 weeks

Other outcomes

Proportion of final value of age at transfer

months

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Lead sponsor

Source ClinicalTrials.gov

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