Enteral NutritionNCT02006953
Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
A study testing Bolus feeding schedule following gastrostomy tube placement and Continuous chimney feeds following gastrostomy tube placement in people with Enteral Nutrition and Enteral Feeding, run by University of Michigan at 2 sites in United States.
Trial summary
The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Enteral Nutrition, Enteral Feeding, Gastrostomy Tube
- What is being tested?
- Bolus feeding schedule following gastrostomy tube placement and Continuous chimney feeds following gastrostomy tube placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to 7 Nov 2018
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 18 years of age
- Admitted for gastrostomy tube placement, with or without Nissen Fundoplication
Who cannot join
- Immunocompromised patients
- Short Bowel Syndrome (SBS)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan, CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Mercy Children's Hospital
Toledo, Ohio, 43608
About this study
The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.
Read the detailed description
This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes
- Conditions
- Enteral Nutrition, Enteral Feeding, Gastrostomy Tube
- Being tested
- Bolus feeding schedule following gastrostomy tube placement, Continuous chimney feeds following gastrostomy tube placement
- Keywords
- gastrostomy, enteral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus feeding schedule following gastrostomy tube placementProcedure or surgery
Continuous chimney feeds following gastrostomy tube placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bolus | Active comparator | Bolus: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Volume of each bolus is determined by dividing the total volume of feeding by the desired number of feedings per day:
If child is less than 6 months: 8 feeds/day If child is 6-12 months 6 feeds/day If child is 12 months or greater: 5 feedings/day Rate of feeds is determine by the rate needed to infuse each bolus over 1 hour. Patient to remain NPO. Once at goal, if able to take PO, may offer orally first with remainder of goal volume over the remainder of the hour. Receives: Procedure: Bolus feeding schedule following gastrostomy tube placement |
| Continuous | Active comparator | Continuous: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Rate of feeds is determined by dividing total volume of feedings by 24 hours. Patient is to remain NPO. Once at goal, if able to take PO, may offer hourly amount orally, but only 2x per day. Receives: Procedure: Continuous chimney feeds following gastrostomy tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of gastrostomy tube leakage
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Secondary outcomes (8)
Emesis
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Retching
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Venting beyond recommendations
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Feeding changes
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Unscheduled clinic/ER visits/calls
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
G-tube infection
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Weight
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Time to goal feeds
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startAug 2011
- Primary completion18 Jul 2018
- Study completion7 Nov 2018
Why it stopped: Difficulty recruiting due to parent declining feeding strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Responsible party
- Principal investigator, Steven W. Bruch, University of Michigan
- Investigators
- Steven W Bruch, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006953
- Sponsor's protocol ID
- HUM00046483
- Status last verified
- Jan 2019
- First submitted
- 5 Dec 2013
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
- ClinicalTrials.gov ID
- NCT02006953
- Acronym / sponsor ID
- HUM00046483
- Conditions
- Enteral Nutrition, Enteral Feeding, Gastrostomy Tube
- Keywords
- gastrostomy, enteral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting due to parent declining feeding strategy
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Study start
- Aug 2011
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 10 Dec 2013 (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.
The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.
Detailed description
This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus | Active comparator | Procedure: Bolus feeding schedule following gastrostomy tube placementBolus: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Volume of each bolus is determined by dividing the total volume of feeding by the desired number of feedings per day: If child is less than 6 months: 8 feeds/day If child is 6-12 months 6 feeds/day If child is 12 months or greater: 5 feedings/day Rate of feeds is determine by the rate needed to infuse each bolus over 1 hour. Patient to remain NPO. Once at goal, if able to take PO, may offer orally first with remainder of goal volume over the remainder of the hour. |
| Continuous | Active comparator | Procedure: Continuous chimney feeds following gastrostomy tube placementContinuous: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Rate of feeds is determined by dividing total volume of feedings by 24 hours. Patient is to remain NPO. Once at goal, if able to take PO, may offer hourly amount orally, but only 2x per day. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Less than 18 years of age
- Admitted for gastrostomy tube placement, with or without Nissen Fundoplication
Key exclusion criteria (2 listed)
- Immunocompromised patients
- Short Bowel Syndrome (SBS)
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 |
|---|---|---|
| Bolus feeding schedule following gastrostomy tube placement | Procedure or surgery | Bolus |
| Continuous chimney feeds following gastrostomy tube placement | Procedure or surgery | Continuous |
Primary outcome
Rate of gastrostomy tube leakage
Time frame: 8 weeks
Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks.
8 secondary outcomes
Emesis
Time frame: 8 weeks
Retching
Time frame: 8 weeks
Venting beyond recommendations
Time frame: 8 weeks
Feeding changes
Time frame: 8 weeks
Unscheduled clinic/ER visits/calls
Time frame: 8 weeks
G-tube infection
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Time to goal feeds
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting due to parent declining feeding strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Steven W Bruch, MD, MSc principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolus feeding schedule following gastrostomy tube placement and Continuous chimney feeds following gastrostomy tube placement in people with Enteral Nutrition and Enteral Feeding, run by University of Michigan at 2 sites in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Difficulty recruiting due to parent declining feeding strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of gastrostomy tube leakage (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.