An interventional study of enteral feeding as per predefined protocol in Duct Dependent Lesions, Necrotising Enterocolitis and Death, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Not yet recruiting at 2 sites in Poland. Open to participants aged 1 Minute to 72 Hours. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Not applicable, Interventional, and Prevention
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 384 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Exclusion criteria:
Patients will receive enteral feeding based on the practice of the leading physician.
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.
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.
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
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
Median change from baseline of caloric intake
kcal/kg/day
Time frame: within 4 weeks
Proportion of final value of days required to reach full enteral feeding
days
Time frame: within 4 weeks
Proportion of final value of days on mechanical ventilation
days
Time frame: within 4 weeks
Proportion of final value of days required to regain birth weight
grams
Time frame: within 4 weeks
Median change from baseline of breastfeeding of > 50%
per study arm
Time frame: within 12 months
Proportion of culture proven late onset sepsis
per group
Time frame: 4 weeks
Proportion of final value of age at transfer
months
Time frame: 4 weeks
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Princess Anna Mazowiecka Hospital, Warsaw, Poland