Acute Pediatric PancreatitisNCT01423786
Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
A study testing Early Oral Nutrition in people with Acute Pediatric Pancreatitis, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Acute Pediatric Pancreatitis
- What is being tested?
- Early Oral Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 16 Jul 2014
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of acute pancreatitis
- Enroll within 24 hours of diagnosis
- At least 50% of baseline diet must be taken orally
Who cannot join
- Evidence of severe pancreatitis
- Diagnosis of chronic pancreatitis
- Patients unable to communicate pain or a desire to eat/drink
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.
- Conditions
- Acute Pediatric Pancreatitis
- Being tested
- Early Oral Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Oral NutritionDietary supplement
Once enrolled in the study, patients will be allowed a oral diet that is low in fat.
| Study group | Role | What they receive |
|---|---|---|
| Please help | Other | Dr. Kumar left Nationwide Children's Hospital in 2014 and efforts to get ahold of her to complete her ct.gov entries have been unsuccessful as we are not able to get ahold of her.
In July 2014, she wrote in her Continuing Review application to the NCH IRB: "34 patients have been recruited and data has mostly been collected. Follow up calls have been made and no adverse events occurred during the study period."
No other information is available. Receives: Dietary Supplement: Early Oral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of Oral Nutrition
The time it takes for the patient to tolerate at least 50% of his/her goal oral calories while maintaining hydration as assessed by urine ouput or fluid intake
Measured: 1 week
Secondary outcomes (1)
Length of Stay
The length of time between admission for acute pancreatitis and discharge.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion16 Jul 2014
- Study completion16 Jul 2014
Why it stopped: Dr. Kumar left Nationwide Children's Hospital. The study expired with the Nationwide Children's Hospital on 7/16/14.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pediatric PancreatitisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423786
- Sponsor's protocol ID
- IRB11-00446
- Other IDs
- 277711
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 7 Aug 2019
- Results posted
- No
Publications
Ellery KM, Kumar S, Crandall W, Gariepy C. The Benefits of Early Oral Nutrition in Mild Acute Pancreatitis. J Pediatr. 2017 Dec;191:164-169. doi: 10.1016/j.jpeds.2017.08.032. Epub 2017 Oct 12.
PubMed 29031861
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
- ClinicalTrials.gov ID
- NCT01423786
- Acronym / sponsor ID
- IRB11-00446
- Conditions
- Acute Pediatric Pancreatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Kumar left Nationwide Children's Hospital. The study expired with the Nationwide Children's Hospital on 7/16/14.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 16 Jul 2014 (actual)
- Study completion
- 16 Jul 2014 (actual)
- First posted
- 26 Aug 2011 (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.
This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Please help | Other | Dietary Supplement: Early Oral NutritionDr. Kumar left Nationwide Children's Hospital in 2014 and efforts to get ahold of her to complete her ct.gov entries have been unsuccessful as we are not able to get ahold of her. In July 2014, she wrote in her Continuing Review application to the NCH IRB: "34 patients have been recruited and data has mostly been collected. Follow up calls have been made and no adverse events occurred during the study period." No other information is available. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of acute pancreatitis
- Enroll within 24 hours of diagnosis
- At least 50% of baseline diet must be taken orally
Key exclusion criteria (3 listed)
- Evidence of severe pancreatitis
- Diagnosis of chronic pancreatitis
- Patients unable to communicate pain or a desire to eat/drink
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 |
|---|---|---|
| Early Oral NutritionOnce enrolled in the study, patients will be allowed a oral diet that is low in fat. | Dietary supplement | Please help |
Primary outcome
Tolerance of Oral Nutrition
Time frame: 1 week
The time it takes for the patient to tolerate at least 50% of his/her goal oral calories while maintaining hydration as assessed by urine ouput or fluid intake
1 secondary outcome
Length of Stay
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Dr. Kumar left Nationwide Children's Hospital. The study expired with the Nationwide Children's Hospital on 7/16/14.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 29031861Ellery KM, Kumar S, Crandall W, Gariepy C. The Benefits of Early Oral Nutrition in Mild Acute Pancreatitis. J Pediatr. 2017 Dec;191:164-169. doi: 10.1016/j.jpeds.2017.08.032. Epub 2017 Oct 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Oral Nutrition in people with Acute Pediatric Pancreatitis, run by Nationwide Children's Hospital at 1 site 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 3 inclusion and 3 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 7 Aug 2019. 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 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: Dr. Kumar left Nationwide Children's Hospital. The study expired with the Nationwide Children's Hospital on 7/16/14.). 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?
Tolerance of Oral Nutrition (time frame: 1 week). 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 NCT01423786, which also lists 1 linked publication.
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 7 Aug 2019.