Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement

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.

Study Overview

• Status: Unknown
• Conditions: Enteral Nutritional Support
• Intervention / Treatment: Dietary supplement: Resumption of feeding 3 hours after PEG placement; Dietary supplement: Resumption of feeding 8 hours after PEG placement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-730
    • Recruiting
    • Department of Gastroenterology, Hepatology and Feeding Disorders
    • Principal Investigator: Jaroslaw Kierkus, Md PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Early enteral nutrition; 3 hours after PEG implantation	Dietary supplement: Resumption of feeding 3 hours after PEG placement; The first feeding will be with polymeric diet (1 kcal/ml). First feeding portion will have the volume equal to 1/3 of full recommended portion, volume of second feeding will be equal to 2/3 of full recommended portion and third portion will be equal to full recommended portion. Each portion will introduced thru the enteral feeding pump (Flocare Infinity, Nutricia), for 30 minutes, three-hour break between feeds. Infusion of 5% glucose solution with electrolytes will be given through intravenous line to cover maintenance fluid requirement in all subjects.
OTHER: Late enteral nutrition; 8 hours after PEG implantation	Dietary supplement: Resumption of feeding 8 hours after PEG placement; The first feeding will be with polymeric diet (1 kcal/ml). First feeding portion will have the volume equal to 1/3 of full recommended portion, volume of second feeding will be equal to 2/3 of full recommended portion and third portion will be equal to full recommended portion. Each portion will introduced thru the enteral feeding pump (Flocare Infinity, Nutricia), for 30 minutes, three-hour break between feeds. Infusion of 5% glucose solution with electrolytes will be given through intravenous line to cover maintenance fluid requirement in all subjects.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of early complications (to 6 days after PEG placement)	to 6 days after PEG placement
Number of late complications ( 7 days - 12 months after PEG placement)	7 days- 12 months after PEG placement
Number of hospitalization days after PEG placement	up to 30 days
Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in nutritional status	number of patients with nutritional status improvement after PEG placement	12 months
Influence of vitamin and trace element deficiency on complications rate.	number of patients with vitamin and trace deficiency before PEG placement who had diagnosed post PEG placement early or late complication.	12 months
Influence of ghrelin, leptin and adiponectin level on nutritional status	number of patients with incorrect ghrelin, leptin or adiponectin level with no post PEG nutritional improvement	12 months
Influence of gastroesophageal reflux (GER) diagnosed before the procedure on feeding tolerance.	number of patients with diagnosed pre PEG GER with no post PEG nutritional improvement	12 months
Corelation between fecal calprotectin level and feeding tolerance after PEG placement	number of patients with elevated calprotectin level before PEG placement who had post PEG placement enteral feeding intolerance	12 months
Influence of oropharyngeal flora on complications rate (wound infection)	number of patients with abnormal oropharyngeal flora with post PEG wound infection	12 months
Correlation between PEG placement and GER	number of patients with post PEG GER	12 months

Collaborators and Investigators

• Sponsor: Children's Memorial Health Institute, Poland
• Collaborators: Nutricia Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): January 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (ESTIMATE): May 19, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: children; percutaneous endoscopic gastrostomy; early enteral nutrition
• Other Study ID Numbers: RG 1/2014