Enteral Nutritional Support Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03742752 -
Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery
|
N/A |