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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.

作者信息

Seliga-Siwecka Joanna, Płotko Ariel, Wójcik-Sep Agata, Bokiniec Renata, Latka-Grot Julita, Żuk Małgorzata, Furmańczyk Konrad, Zieliński Wojciech, Chrzanowska Mariola

机构信息

Department of Neonatology and Neonatal Intensive Care, Medical University of Warsaw, Warsaw, Poland.

Department of Neonatology, Children's Health Memorial Institute, Warsaw, Poland.

出版信息

Front Cardiovasc Med. 2022 Sep 8;9:893764. doi: 10.3389/fcvm.2022.893764. eCollection 2022.


DOI:10.3389/fcvm.2022.893764
PMID:36158805
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9492877/
Abstract

BACKGROUND: Infants with duct dependent heart lesions often require invasive procedures during the neonatal or early infancy period. These patients remain a challenge for pediatric cardiologists, neonatologists, and intensive care unit personnel. A relevant portion of these infant suffer from respiratory, cardiac failure and may develop NEC, which leads to inadequate growth and nutrition, causing delayed or complicated cardiac surgery. METHODS: This randomized control trial will recruit term infants diagnosed with a duct dependant lesion within the first 72 h of life. After obtaining written parental consent patients will be randomized to either the physician led enteral feeding or protocol-based feeding group. The intervention will continue up to 28 days of life or day of cardiosurgical treatment, whichever comes first. The primary outcomes include NEC and death related to NEC. Secondary outcomes include among others, number of interrupted feedings, growth velocity, daily protein and caloric intake, days to reach full enteral feeding and on mechanical ventilation. DISCUSSION: Our study will be the first randomized control trial to evaluate if standard (as in healthy newborns) initiation and advancement of enteral feeding is safe, improves short term outcomes and does not increase the risk of NEC. If the studied feeding regime proves to be intact, swift implementation and advancement of enteral nutrition may become a recommendation. TRIAL REGISTRATION: The study protocol has been approved by the local ethical board. It is registered at ClinicalTrials.gov NCT05117164.

摘要

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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.

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本文引用的文献

[1]
Development of necrotizing enterocolitis in full-term infants with duct dependent congenital heart disease.

BMC Pediatr. 2022-4-2

[2]
Necrotizing Enterocolitis in Children with Congenital Heart Disease: A Literature Review.

Pediatr Cardiol. 2021-12

[3]
Missing Data in Clinical Research: A Tutorial on Multiple Imputation.

Can J Cardiol. 2021-9

[4]
A Multi-Interventional Nutrition Program for Newborns with Congenital Heart Disease.

J Pediatr. 2021-1

[5]
Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations.

Intensive Care Med. 2020-3

[6]
Preoperative Feeds in Ductal-Dependent Cardiac Disease: A Systematic Review and Meta-analysis.

Hosp Pediatr. 2019-12

[7]
The REDCap consortium: Building an international community of software platform partners.

J Biomed Inform. 2019-5-9

[8]
Optimisation of children z-score calculation based on new statistical techniques.

PLoS One. 2018-12-20

[9]
Standardized Feeding Protocols to Reduce Risk of Necrotizing Enterocolitis in Fragile Infants Born Premature or with Congenital Heart Disease: Implementation Science Needed.

Crit Care Nurs Clin North Am. 2018-12

[10]
Cardiogenic Necrotizing Enterocolitis: A Clinically Distinct Entity from Classical Necrotizing Enterocolitis.

Eur J Pediatr Surg. 2019-2

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