Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nutricia Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Tertiary endpoints:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early enteral nutrition | Other | 3 hours after PEG implantation |
|
| Late enteral nutrition | Other | 8 hours after PEG implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resumption of feeding 3 hours after PEG placement | Dietary Supplement | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaroslaw Kierkus | Contact | +48 22 815 73 84 | j.kierkus@czd.pl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Hepatology and Feeding Disorders | Recruiting | Warsaw | 04-730 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30197271 | Derived | 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. | |
| 27717336 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Resumption of feeding 8 hours after PEG placement | Dietary Supplement | 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. |
|
| 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 |
| 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 |
| Derived |
| 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. |