Health, Economic Analysis and Clinical Aspects of Patients With Neurological Disabilities in Enteral Nutrition With Dedicated Formula. The Role of Nissen's Fundoplication in the Management of Gastroesophageal Reflux

NCT05068089 | Unknown

• 1 other identifier: 2322_Opbg_2021
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Nutritional difficulties are common in children with neurodisabilities and can be associated with malnutrition and gastrointestinal diseases, such as gastro-esophageal reflux disease (GERD) and constipation. Neurological disorders can be divided into two main categories: progressive (neurodegenerative, mitochondrial disease) and non-progressive (cerebral palsy) neurodisabilities; nature of the disorders can impair on the nutritional status of these children. In 2017, ESGHAN published guidelines with specific nutritional claims. Approximately 46%-90% of children with neurodisabilities suffer from malnutrition and an enteral feeding is necessary to reach the nutritional requirements. In addition, a relevant issue for these children is GERD, reaching up to 70% prevalence. The treatment of GERD could be based on pharmacological therapy (protonic pomp inhibitor, PPI), on nutritional treatment (changing type of formula) or on surgical treatment (Nissen Fundoplication). European guidelines for GERD recommend PPI as the first line, with fundoplication being considered in cases of failure of optimized medical therapy. Enteral feeding can be considered in order to avoid malnutrition and is justified when other efforts to increase nutritional intake. Enteral feeding can be provided by nasal tube at the beginning, but a gastrostomy feeding tube would be preferred for a long-term nutrition (greater than six weeks). A jejunal tube can be introduced through the gastrostomy; jejunal feeding is appropriate in patients with recurrent vomiting and/or tube feeding-related aspiration, severe gastroesophageal reflux, and gastroparesis. Different types of formulas can be used for enteral nutrition and can be offered by nasal tube, percutaneous endoscopic gastrostomy (PEG) or percutaneous endoscopic jejunostomy (PEJ). Whey-based formulas have been shown to empty from the stomach more rapidly than casein-based formulas, which may be helpful for patients presenting with delayed gastric emptying. Use of peptide-based, 100% whey protein formulas are associated with improved feeding tolerance, increased consistency in meeting nutritional needs, and a reduction in gastrointestinal issues associated with vomiting and aspiration of feeds. For these reasons, the aim of this study is to retrospectively evaluate the role of different formulas against Nissen fundoplication, regarding tolerance, utility, applicability and safeness of these products, by performing a cost analysis.

Conditions

Gastro-Esophageal Reflux; Fundoplication

Outcome Measures

Primary Outcomes (1)

• To identify the annual economic impact related to the treatment of patients undergoing NF surgery and the costs related to patients undergoing enteral nutrition, analyzing type of formula offered.

  Annual economic impact expressed in Euro, calculated by Health Direction based on specific invoice (SDO) and specific calculator (provided by Italy Ministry of Health); length of hospitalization expressed in days

  11 years

Secondary Outcomes (2)

• To evaluate whether the need for NF is postponed or reduced in the patient population fed with enteral formulas based on whey proteins

  11 years

• Describe and quantify the occurrence of GI disorders associated with different types of enteral nutritional formulas (whey protein vs caseinates)

  11 years

Study Arms (1)

Nissen fundoplication surgery and Enteral nutrition

The cohort population retrospectively enrolled in the study is represented by pediatric patients with severe motor and intellectual disabilities (with progressive e non- progressive neurological disease) followed-up at Nutrition Unit of Ospedale Pediatrico Bambino Gesù between January 2009 to January 2020.

Procedure: Nissen fundoplication; Biological: Enteral nutrition

Interventions

Nissen fundoplication PROCEDURE

Nissen fundoplication, numbers, reasons and length of hospitalizations, gastrointestinal symptoms and survival

Nissen fundoplication surgery and Enteral nutrition

Enteral nutrition BIOLOGICAL

Type and switch of enteral nutrition formula (tube, PEG, PEJ)

Nissen fundoplication surgery and Enteral nutrition

Eligibility Criteria

• Age: 29 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes children with neurological damage (0-18 years) treated in the Nutritional Clinic Department from January 2009 to January 2020 due to nutritional problems and food and / or gastrointestinal intolerances.

You may qualify if:

• Patients diagnosed with severe motor and intellectual disabilities (SMID);
• Pediatric patients ( 29 days; \<18 years);
• Subjects whose enteral nutrition through a nasogastric tube or endoscopic gastrostomy; percutaneous (PEG) involves the administration of a special formula based on whey protein or a formula based on caseinates;
• Subjects undergoing or not NF surgery.

You may not qualify if:

• Patients less than 24 months of follow-up at the closing of the database;
• Patients with less than 12 months of observation.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• Nestlé Health Science Spain: collaborator

Study Sites (1)

IRCCS, Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

Location

Related Publications (6)

• Romano C, van Wynckel M, Hulst J, Broekaert I, Bronsky J, Dall'Oglio L, Mis NF, Hojsak I, Orel R, Papadopoulou A, Schaeppi M, Thapar N, Wilschanski M, Sullivan P, Gottrand F. European Society for Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Neurological Impairment. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):242-264. doi: 10.1097/MPG.0000000000001646.

  PMID: 28737572 BACKGROUND

• Hasegawa M, Tomiwa K, Higashiyama Y, Kawaguchi C, Kin H, Kubota M, Shima M, Nogami K. Risk factors of malnutrition in children with severe motor and intellectual disabilities. Brain Dev. 2020 Nov;42(10):738-746. doi: 10.1016/j.braindev.2020.06.009. Epub 2020 Jul 2.

  PMID: 32624241 BACKGROUND

• van den Engel-Hoek L, de Groot IJ, de Swart BJ, Erasmus CE. Feeding and Swallowing Disorders in Pediatric Neuromuscular Diseases: An Overview. J Neuromuscul Dis. 2015 Nov 20;2(4):357-369. doi: 10.3233/JND-150122.

  PMID: 27858755 BACKGROUND

• Sullivan PB. Gastrointestinal disorders in children with neurodevelopmental disabilities. Dev Disabil Res Rev. 2008;14(2):128-36. doi: 10.1002/ddrr.18.

  PMID: 18646021 BACKGROUND

• Savage K, Kritas S, Schwarzer A, Davidson G, Omari T. Whey- vs casein-based enteral formula and gastrointestinal function in children with cerebral palsy. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):118S-23S. doi: 10.1177/0148607111428139.

  PMID: 22237871 BACKGROUND

• Minor G, Ochoa JB, Storm H, Periman S. Formula Switch Leads to Enteral Feeding Tolerance Improvements in Children With Developmental Delays. Glob Pediatr Health. 2016 Dec 21;3:2333794X16681887. doi: 10.1177/2333794X16681887. eCollection 2016.

  PMID: 28229094 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication; Enteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Antonella Diamanti, MD

CONTACT

0668592077; antonella.diamanti@opbg.net

Chiara Maria Trovato

CONTACT

0668592077; chiaramaria.trovato@opbg.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 5, 2021
• Study Start: November 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)