Enteral Feeding in Infants With Duct Dependant Lesions.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.

Conditions
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Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth

Intervention / Treatment
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* Other: enteral feeding as per predefined protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients will receive enteral feeding based on the practice of the leading physician. | |
| Experimental: intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of final diagnosis of necrotizing enterocolitis (NEC). | Number of infants diagnosed with NEC. | up to two weeks life | 
| Proportion of death | Death rate. | up to two weeks life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | centimeters per week. | Number of infants with a significant median change from baseline within 12 months | 
| Proportion of number of interrupted feedings | per day. | final value within 4 weeks | 
| Final median value of Vasoactive support | per day. | within 4 weeks | 
| Median change from baseline of protein intake | grams/kg | within 4 weeks | 
| Median change from baseline of caloric intake | kcal/kg/day | within 4 weeks | 
| Proportion of final value of days required to reach full enteral feeding | days | within 4 weeks | 
| Proportion of final value of days on mechanical ventilation | days | within 4 weeks | 
| Proportion of final value of days required to regain birth weight | grams | within 4 weeks | 
| Median change from baseline of breastfeeding of > 50% | per study arm | within 12 months | 
| Proportion of culture proven late onset sepsis | per group | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, nutrition, growth, newborn