Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 384
- Locations
- 2
- Primary Endpoint
- Proportion of death
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Minute to 72 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •> 50% formula based enteral feeding
- •Birth weight less than 2500g
Arms & Interventions
control group
Patients will receive enteral feeding based on the practice of the leading physician.
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.
Intervention: enteral feeding as per predefined protocol (Other)
Outcomes
Primary Outcomes
Proportion of death
Time Frame: up to two weeks life
Death rate.
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
Time Frame: up to two weeks life
Number of infants diagnosed with NEC.
Secondary Outcomes
- Final median value of Vasoactive support(within 4 weeks)
- Median change from baseline of protein intake(within 4 weeks)
- Proportion of number of interrupted feedings(final value within 4 weeks)
- Proportion of final value of days required to reach full enteral feeding(within 4 weeks)
- Median change from baseline of caloric intake(within 4 weeks)
- Proportion of final value of days on mechanical ventilation(within 4 weeks)
- Proportion of final value of days required to regain birth weight(within 4 weeks)
- Median change from baseline of breastfeeding of > 50%(within 12 months)
- Proportion of culture proven late onset sepsis(4 weeks)
- growth(Number of infants with a significant median change from baseline within 12 months)
Investigators
Joanna Seliga-Siwecka
Principal investigator
Princess Anna Mazowiecka Hospital, Warsaw, Poland