Clinical trial NCT02777541: Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
Official title: Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Nutritional Support
Keywords: early enteral nutrition
children
percutaneous endoscopic gastrostomy
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2016-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There aren't sufficient randomized prospective controlled trials in pediatric population comparing the safety and tolerance of early feeding after PEG placement (3-4 hours). Most patients are fasted for at least 12 hours following percutaneous endoscopic gastrostomy. In order to decrease the period of fasting, inadequate nutritional support, and hospitalization time, the investigators decided to design this study. The additional goal is to establish an optimum standard procedure in the group of pediatric patients qualified for PEG insertion procedure in Poland.

Detailed description: This study is a multicentre, randomized, open label trial designed to evaluate the tolerance and safety of early enteral nutrition after PEG placement in children. Recruitment will be from patients attending the one of six medical centers in Poland: Department of Gastroenterology, Hepatology and Feeding Disorders and Department of Pediatrics, The Children's Memorial Health Institute in Warsaw, Department of Pediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk in Gdańsk, Department of Allergology, Gastroenterology and Nutrition, Medical University in Łódź, Department of Pediatrics, Medical University of Silesia in Katowice and Department of Pediatrics and Gastroenterology, Area Hospital in Torus.

The trial will include 100 patients, from 1-month-old to 18-year-old, qualified for percutaneous endoscopic gastrostomy (PEG) placement. All participants will be prepared for the procedure according to the standard medical protocol.

Parents/legal guardians, and where possible also the patient, will be informed about the research plan, and after signed informed consent to participate in the study patients will be enrolled for the study. At the Baseline visit participants will be randomized (1:1) to one of two treatment group: Group I- early enteral feeding group (3 hours after PEG implantation) or Group II- late enteral feeding group (8 hours after PEG implantation). The follow-up visits in hospital is planned 3, 6, 9 mad 12 months after the procedure in all subjects.

Primary endpoint:

1. Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.

Secondary endpoints:

1. Number of early complications (to 6 days after PEG placement)
2. Number of late complications ( 7 days - 12 months after PEG placement)
3. Duration of hospitalization after PEG placement (in days)
4. Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus

Tertiary endpoints:

1. Improvement in nutritional status (3,6,9,12 months after the procedure) - body weight gain (kg) and height gain (cm), BMI kg/m2
2. Influence of vitamin and trace element deficiency (vitamin D - 25(OH)D3, vitamin A, vitamin E, sodium, potassium, calcium, zinc, iron, magnesium, selenium) and other biochemical parameters abnormalities (serum level of urea, total protein, albumin, glucose, glycated hemoglobin (hemoglobin HbA1c), aspartate transaminase (AST), alanine transaminase (ALT), ferritin, C reactive protein) on complications rate.
3. Influence of ghrelin, leptin and adiponectin level on nutritional status improvement after PEG placement.
4. Influence of gastroesophageal reflux (GER) diagnosed before the procedure on feeding tolerance.
5. Corelation between fecal calprotectin level and feeding tolerance after PEG placement, complication rate and nutritional status before PEG placement.
6. Influence of oropharyngeal flora on complications rate (wound infection)
7. Correlation between PEG placement and GER.

Eligibility criteria: Inclusion Criteria:

1. Subjects between 1 month-old and 18 years-old
2. Medical indications for percutaneous endoscopic gastrostomy (PEG) placement.
3. Informed consent to participate in the study signed and dated by the subject's parent/legal guardian and the also by patient over the age of 16 years.

Exclusion Criteria:

1. Serious, uncorrectable coagulation disorders.
2. Inability to perform upper gastrointestinal (UGI) series endoscopy (laryngeal or oesophageal stricture)
3. Need for concomitant fundoplication.
4. Lack of technical ability to perform PEG placement procedure

Primary outcomes:
measure: Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
timeFrame: 48 hours
Secondary outcomes:
measure: Number of early complications (to 6 days after PEG placement)
timeFrame: to 6 days after PEG placement
measure: Number of late complications ( 7 days - 12 months after PEG placement)
timeFrame: 7 days- 12 months after PEG placement
measure: Number of hospitalization days after PEG placement
timeFrame: up to 30 days
measure: Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus
timeFrame: 48 hours
Other outcomes:
measure: Improvement in nutritional status
timeFrame: 12 months
measure: Influence of vitamin and trace element deficiency on complications rate.
timeFrame: 12 months
measure: Influence of ghrelin, leptin and adiponectin level on nutritional status
timeFrame: 12 months
measure: Influence of gastroesophageal reflux (GER) diagnosed before the procedure on feeding tolerance.
timeFrame: 12 months
measure: Corelation between fecal calprotectin level and feeding tolerance after PEG placement
timeFrame: 12 months
measure: Influence of oropharyngeal flora on complications rate (wound infection)
timeFrame: 12 months
measure: Correlation between PEG placement and GER
timeFrame: 12 months
Locations:
city: Warsaw
country: Poland
facility: Department of Gastroenterology, Hepatology and Feeding Disorders
Study officials:
References:
citation: Wiernicka A, Matuszczyk M, Szlagatys-Sidorkiewicz A, Landowski P, Toporowska-Kowalska E, Gebora-Kowalska B, Popinska K, Sibilska M, Grzybowska-Chlebowczyk U, Wiecek S, Hapyn E, Blimke-Koziel K, Kierkus J. Tolerability and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement: A multicentre randomised controlled trial. Clin Nutr. 2019 Aug;38(4):1544-1548. doi: 10.1016/j.clnu.2018.08.018. Epub 2018 Aug 28.
citation: Wiernicka A, Matuszczyk M, Szlagatys-Sidorkiewicz A, Toporowska-Kowalska E, Popinska K, Chlebowczyk-Grzybowska U, Hapyn E, Kierkus J. The protocol for a randomised-controlled trial of the evaluation of the tolerance and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement. (protocol version 09.01.2015). BMC Pediatr. 2016 Oct 7;16(1):163. doi: 10.1186/s12887-016-0705-8.