Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 20, 2016
May 1, 2016
2 years
May 16, 2016
May 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
48 hours
Secondary Outcomes (4)
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 Outcomes (7)
Improvement in nutritional status
12 months
Influence of vitamin and trace element deficiency on complications rate.
12 months
Influence of ghrelin, leptin and adiponectin level on nutritional status
12 months
- +4 more other outcomes
Study Arms (2)
Early enteral nutrition
OTHER3 hours after PEG implantation
Late enteral nutrition
OTHER8 hours after PEG implantation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Subjects between 1 month-old and 18 years-old
- Medical indications for percutaneous endoscopic gastrostomy (PEG) placement.
- 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.
You may not qualify if:
- Serious, uncorrectable coagulation disorders.
- Inability to perform upper gastrointestinal (UGI) series endoscopy (laryngeal or oesophageal stricture)
- Need for concomitant fundoplication.
- Lack of technical ability to perform PEG placement procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Memorial Health Institute, Polandlead
- Nutricia Foundationcollaborator
Study Sites (1)
Department of Gastroenterology, Hepatology and Feeding Disorders
Warsaw, 04-730, Poland
Related Publications (2)
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.
PMID: 30197271DERIVEDWiernicka 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.
PMID: 27717336DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 19, 2016
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
December 1, 2017
Last Updated
May 20, 2016
Record last verified: 2016-05