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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Patients will receive enteral feeding based on the practice of the leading physician. | |
| intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral feeding as per predefined protocol | Other | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of final value of age at transfer | months | 4 weeks |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel Płotko, MD | Contact | 004822596136 | plotko.ariel@gmail.com | |
| Renata Bokiniec, MD PhD | Contact | 004822596155 | rbokiniec@wp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Renata Bokiniec, MD PhD | Medical University of Warsaw | Study Chair |
| Joanna Seliga-Siwecka, MD PhD | Medical University of Warsaw | Study Director |
| Ariel Płotko |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Warsaw | 00-315 | Poland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36158805 | Derived | Seliga-Siwecka J, Plotko A, Wojcik-Sep A, Bokiniec R, Latka-Grot J, Zuk M, Furmanczyk K, Zielinski W, Chrzanowska M. Effect of standardized vs. local preoperative enteral feeding practice on the incidence of NEC in infants with duct dependent lesions: Protocol for a randomized control trial. Front Cardiovasc Med. 2022 Sep 8;9:893764. doi: 10.3389/fcvm.2022.893764. eCollection 2022. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D003643 | Death |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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|
| 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 |
| Medical University of Warsaw |
| Principal Investigator |
| Agata Wojcik-Sep | Medical University of Warsaw | Principal Investigator |
| Princess Anna Mazowiecka Hospital |
| Warsaw |
| 00-315 |
| Poland |
|
| D007410 |
| Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |