Enteral Nutritional SupportNCT02777541
Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
A study testing Resumption of feeding 3 hours after PEG placement and Resumption of feeding 8 hours after PEG placement in people with Enteral Nutritional Support, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Enteral Nutritional Support
- What is being tested?
- Resumption of feeding 3 hours after PEG placement and Resumption of feeding 8 hours after PEG placement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Hepatology and Feeding Disorders
Warsaw, 04-730
Jaroslaw Kierkus, +48 22 815 73 84, j.kierkus@czd.pl
Jaroslaw Kierkus, Md PhD
About this study
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.
Read the 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:
- Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
Secondary endpoints:
- Number of early complications (to 6 days after PEG placement)
- Number of late complications ( 7 days - 12 months after PEG placement)
- Duration of hospitalization after PEG placement (in days)
- Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus
Tertiary endpoints:
- Improvement in nutritional status (3,6,9,12 months after the procedure) - body weight gain (kg) and height gain (cm), BMI kg/m2
- 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.
- Influence of ghrelin, leptin and adiponectin level on nutritional status improvement after PEG placement.
- Influence of gastroesophageal reflux (GER) diagnosed before the procedure on feeding tolerance.
- Corelation between fecal calprotectin level and feeding tolerance after PEG placement, complication rate and nutritional status before PEG placement.
- Influence of oropharyngeal flora on complications rate (wound infection)
- Correlation between PEG placement and GER.
- Conditions
- Enteral Nutritional Support
- Being tested
- Resumption of feeding 3 hours after PEG placement, Resumption of feeding 8 hours after PEG placement
- Keywords
- early enteral nutrition, children, percutaneous endoscopic gastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resumption of feeding 3 hours after PEG placementDietary 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.
Resumption of feeding 8 hours after PEG placementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Early enteral nutrition | Other | 3 hours after PEG implantation Receives: Dietary Supplement: Resumption of feeding 3 hours after PEG placement |
| Late enteral nutrition | Other | 8 hours after PEG implantation Receives: Dietary Supplement: Resumption of feeding 8 hours after PEG placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
Measured: 48 hours
Secondary outcomes (4)
Number of early complications (to 6 days after PEG placement)
Measured: to 6 days after PEG placement
Number of late complications ( 7 days - 12 months after PEG placement)
Measured: 7 days- 12 months after PEG placement
Number of hospitalization days after PEG placement
Measured: up to 30 days
Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral Nutritional SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation
- Responsible party
- Principal investigator, JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777541
- Sponsor's protocol ID
- RG 1/2014
- Status last verified
- May 2016
- First submitted
- 16 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30197271Wiernicka 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.
PubMed 27717336
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
- ClinicalTrials.gov ID
- NCT02777541
- Acronym / sponsor ID
- RG 1/2014
- Conditions
- Enteral Nutritional Support
- Keywords
- early enteral nutrition, children, percutaneous endoscopic gastrostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Collaborators
- Nutricia Foundation
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
Secondary endpoints:
- Number of early complications (to 6 days after PEG placement)
- Number of late complications ( 7 days - 12 months after PEG placement)
- Duration of hospitalization after PEG placement (in days)
- Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus
Tertiary endpoints:
- Improvement in nutritional status (3,6,9,12 months after the procedure) - body weight gain (kg) and height gain (cm), BMI kg/m2
- 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.
- Influence of ghrelin, leptin and adiponectin level on nutritional status improvement after PEG placement.
- Influence of gastroesophageal reflux (GER) diagnosed before the procedure on feeding tolerance.
- Corelation between fecal calprotectin level and feeding tolerance after PEG placement, complication rate and nutritional status before PEG placement.
- Influence of oropharyngeal flora on complications rate (wound infection)
- Correlation between PEG placement and GER.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early enteral nutrition | Other | Dietary Supplement: Resumption of feeding 3 hours after PEG placement3 hours after PEG implantation |
| Late enteral nutrition | Other | Dietary Supplement: Resumption of feeding 8 hours after PEG placement8 hours after PEG implantation |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resumption of feeding 3 hours after PEG placementThe 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. | Dietary supplement | Early enteral nutrition |
| Resumption of feeding 8 hours after PEG placementThe 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. | Dietary supplement | Late enteral nutrition |
Primary outcome
Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
Time frame: 48 hours
4 secondary outcomes
Number of early complications (to 6 days after PEG placement)
Time frame: to 6 days after PEG placement
Number of late complications ( 7 days - 12 months after PEG placement)
Time frame: 7 days- 12 months after PEG placement
Number of hospitalization days after PEG placement
Time frame: up to 30 days
Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Derived from this study: PubMed 30197271Wiernicka 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.
- Derived from this study: PubMed 27717336Wiernicka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resumption of feeding 3 hours after PEG placement and Resumption of feeding 8 hours after PEG placement in people with Enteral Nutritional Support, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaroslaw Kierkus (+48 22 815 73 84, j.kierkus@czd.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.