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

Enteral Nutritional Support Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777541
• Other study ID #: RG 1/2014
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2016
• Last updated: May 18, 2016
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Children's Memorial Health Institute, Poland
• Contact: Jaroslaw Kierkus
• Phone: +48 22 815 73 84
• Email: j.kierkus[@]czd.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Enteral Nutritional Support

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Department of Gastroenterology, Hepatology and Feeding Disorders	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Children's Memorial Health Institute, Poland	Nutricia Foundation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in nutritional status	number of patients with nutritional status improvement after PEG placement	12 months	No
Other	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	Yes
Other	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	No
Other	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	No
Other	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	No
Other	Influence of oropharyngeal flora on complications rate (wound infection)	number of patients with abnormal oropharyngeal flora with post PEG wound infection	12 months	Yes
Other	Correlation between PEG placement and GER	number of patients with post PEG GER	12 months	No
Primary	Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.		48 hours	Yes
Secondary	Number of early complications (to 6 days after PEG placement)		to 6 days after PEG placement	Yes
Secondary	Number of late complications ( 7 days - 12 months after PEG placement)		7 days- 12 months after PEG placement	Yes
Secondary	Number of hospitalization days after PEG placement		up to 30 days	No
Secondary	Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus		48 hours	No