Short Bowel SyndromeNCT01946503
Infant & Toddler Short Gut Feeding Outcomes Study
An observational study of Short Bowel Syndrome and Intestinal Failure, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to better understand why children with short gut develop feeding problems. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome, Intestinal Failure, Home Parenteral Nutrition
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 May 2023
- Phase
- Observational
- 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 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients seen in home-TPN clinic and subjects who meet the inclusion criteria will be invited to participate.
Who may be able to join
- Patients seen in home-TPN clinic since July of 2008 with:
- Intestinal failure
- Short gut
- Onset < 3 months of age
- Received home parenteral nutrition following initial hospital discharge
- Less than 7 years of age at time of study
- Must have at least 1 parent/legal guradian willing to participate in the study
Who cannot join
- Not seen in home TPN clinic
- Short gut with onset >3 months
- No parents/legal guradians willing to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
The purpose of this study is to better understand why children with short gut develop feeding problems.
Read the detailed description
We seek to identify characteristics of our patients' histories that are associated with feeding problems in the context of availability of early prophylactic occupational therapy. We plan to review our most recent four years' experience in children with short gut syndrome with onset in early infancy who initially required home parenteral nutrition to identify risk factors or clusters of risk factors associated with food aversion.
- Keywords
- Short Gut, Short Bowel Syndrome, Intestinal Failure, Home parenteral nutrition, Feeding Behavior, Enteral Nutrition, Parent-Child Relations, Parenteral Nutrition, Digestive System Diseases
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure, Feeding Behavior, Hyperphagia, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short bowel syndrome | Patients followed in a clinic for short bowel syndrome | |
| Healthy controls | Patients seen in a general pediatric clinic without chronic or acute diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective data
Data will be reviewed starting at the patient's birth. We will only be looking at patients who have been seen in the clinic since July 1, 2008; some of these will have medical records going back as early as 2006. We will continue to collect future data for up to 1 year from the beginning of data collection.
Measured: up to 1 year
Secondary outcomes (1)
Validated Questionnaires
Validated questionnaires (where available) will be administered prospectively to grade current feeding competence for age, assess developmental status, assess food preferences and score parental stress. Only the food preference questionnaire will be administered to the healthy control group.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startApr 2013
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Merritt, Children's Hospital Los Angeles
- Investigators
- Russell J Merritt, MD, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946503
- Sponsor's protocol ID
- CCI-13-00053
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2013
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bazyk S. Factors associated with the transition to oral feeding in infants fed by nasogastric tubes. Am J Occup Ther. 1990 Dec;44(12):1070-8. doi: 10.5014/ajot.44.12.1070.
PubMed 2126165Black MM, Aboud FE. Responsive feeding is embedded in a theoretical framework of responsive parenting. J Nutr. 2011 Mar;141(3):490-4. doi: 10.3945/jn.110.129973. Epub 2011 Jan 26.
PubMed 21270366Byars KC, Burklow KA, Ferguson K, O'Flaherty T, Santoro K, Kaul A. A multicomponent behavioral program for oral aversion in children dependent on gastrostomy feedings. J Pediatr Gastroenterol Nutr. 2003 Oct;37(4):473-80. doi: 10.1097/00005176-200310000-00014.
PubMed 14508219Davies WH, Satter E, Berlin KS, Sato AF, Silverman AH, Fischer EA, Arvedson JC, Rudolph CD. Reconceptualizing feeding and feeding disorders in interpersonal context: the case for a relational disorder. J Fam Psychol. 2006 Sep;20(3):409-17. doi: 10.1037/0893-3200.20.3.409.
PubMed 16937997Engstrom I, Bjornestam B, Finkel Y. Psychological distress associated with home parenteral nutrition in Swedish children, adolescents, and their parents: preliminary results. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):246-50. doi: 10.1097/00005176-200309000-00008.
PubMed 12960644Geertsma MA, Hyams JS, Pelletier JM, Reiter S. Feeding resistance after parenteral hyperalimentation. Am J Dis Child. 1985 Mar;139(3):255-6. doi: 10.1001/archpedi.1985.02140050049020.
PubMed 3919567Lacaille F, Vass N, Sauvat F, Canioni D, Colomb V, Talbotec C, De Serre NP, Salomon J, Hugot JP, Cezard JP, Revillon Y, Ruemmele FM, Goulet O. Long-term outcome, growth and digestive function in children 2 to 18 years after intestinal transplantation. Gut. 2008 Apr;57(4):455-61. doi: 10.1136/gut.2007.133389. Epub 2007 Dec 13.
PubMed 18079282Gottrand F, Staszewski P, Colomb V, Loras-Duclaux I, Guimber D, Marinier E, Breton A, Magnificat S. Satisfaction in different life domains in children receiving home parenteral nutrition and their families. J Pediatr. 2005 Jun;146(6):793-7. doi: 10.1016/j.jpeds.2005.01.034.
PubMed 15973321Pedersen SD, Parsons HG, Dewey D. Stress levels experienced by the parents of enterally fed children. Child Care Health Dev. 2004 Sep;30(5):507-13. doi: 10.1111/j.1365-2214.2004.00437.x.
PubMed 15320927Wilken M. The impact of child tube feeding on maternal emotional state and identity: a qualitative meta-analysis. J Pediatr Nurs. 2012 Jun;27(3):248-55. doi: 10.1016/j.pedn.2011.01.032. Epub 2011 Mar 15.
PubMed 22525813
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant & Toddler Short Gut Feeding Outcomes Study
- ClinicalTrials.gov ID
- NCT01946503
- Acronym / sponsor ID
- CCI-13-00053
- Keywords
- Short Gut, Short Bowel Syndrome, Intestinal Failure, Home parenteral nutrition, Feeding Behavior, Enteral Nutrition, Parent-Child Relations, Parenteral Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Sep 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 better understand why children with short gut develop feeding problems.
Detailed description
We seek to identify characteristics of our patients' histories that are associated with feeding problems in the context of availability of early prophylactic occupational therapy. We plan to review our most recent four years' experience in children with short gut syndrome with onset in early infancy who initially required home parenteral nutrition to identify risk factors or clusters of risk factors associated with food aversion.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short bowel syndrome | – | –Patients followed in a clinic for short bowel syndrome |
| Healthy controls | – | –Patients seen in a general pediatric clinic without chronic or acute diseases |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients seen in home-TPN clinic and subjects who meet the inclusion criteria will be invited to participate.
Key inclusion criteria (7 listed)
- Patients seen in home-TPN clinic since July of 2008 with:
- Intestinal failure
- Short gut
- Onset < 3 months of age
- Received home parenteral nutrition following initial hospital discharge
Key exclusion criteria (3 listed)
- Not seen in home TPN clinic
- Short gut with onset >3 months
- No parents/legal guradians willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective data
Time frame: up to 1 year
Data will be reviewed starting at the patient's birth. We will only be looking at patients who have been seen in the clinic since July 1, 2008; some of these will have medical records going back as early as 2006. We will continue to collect future data for up to 1 year from the beginning of data collection.
1 secondary outcome
Validated Questionnaires
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 2126165Bazyk S. Factors associated with the transition to oral feeding in infants fed by nasogastric tubes. Am J Occup Ther. 1990 Dec;44(12):1070-8. doi: 10.5014/ajot.44.12.1070.
- Background: PubMed 21270366Black MM, Aboud FE. Responsive feeding is embedded in a theoretical framework of responsive parenting. J Nutr. 2011 Mar;141(3):490-4. doi: 10.3945/jn.110.129973. Epub 2011 Jan 26.
- Background: PubMed 14508219Byars KC, Burklow KA, Ferguson K, O'Flaherty T, Santoro K, Kaul A. A multicomponent behavioral program for oral aversion in children dependent on gastrostomy feedings. J Pediatr Gastroenterol Nutr. 2003 Oct;37(4):473-80. doi: 10.1097/00005176-200310000-00014.
- Background: PubMed 16937997Davies WH, Satter E, Berlin KS, Sato AF, Silverman AH, Fischer EA, Arvedson JC, Rudolph CD. Reconceptualizing feeding and feeding disorders in interpersonal context: the case for a relational disorder. J Fam Psychol. 2006 Sep;20(3):409-17. doi: 10.1037/0893-3200.20.3.409.
- Background: PubMed 12960644Engstrom I, Bjornestam B, Finkel Y. Psychological distress associated with home parenteral nutrition in Swedish children, adolescents, and their parents: preliminary results. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):246-50. doi: 10.1097/00005176-200309000-00008.
- Background: PubMed 3919567Geertsma MA, Hyams JS, Pelletier JM, Reiter S. Feeding resistance after parenteral hyperalimentation. Am J Dis Child. 1985 Mar;139(3):255-6. doi: 10.1001/archpedi.1985.02140050049020.
- Background: PubMed 18079282Lacaille F, Vass N, Sauvat F, Canioni D, Colomb V, Talbotec C, De Serre NP, Salomon J, Hugot JP, Cezard JP, Revillon Y, Ruemmele FM, Goulet O. Long-term outcome, growth and digestive function in children 2 to 18 years after intestinal transplantation. Gut. 2008 Apr;57(4):455-61. doi: 10.1136/gut.2007.133389. Epub 2007 Dec 13.
- Background: PubMed 15973321Gottrand F, Staszewski P, Colomb V, Loras-Duclaux I, Guimber D, Marinier E, Breton A, Magnificat S. Satisfaction in different life domains in children receiving home parenteral nutrition and their families. J Pediatr. 2005 Jun;146(6):793-7. doi: 10.1016/j.jpeds.2005.01.034.
- Background: PubMed 15320927Pedersen SD, Parsons HG, Dewey D. Stress levels experienced by the parents of enterally fed children. Child Care Health Dev. 2004 Sep;30(5):507-13. doi: 10.1111/j.1365-2214.2004.00437.x.
- Background: PubMed 22525813Wilken M. The impact of child tube feeding on maternal emotional state and identity: a qualitative meta-analysis. J Pediatr Nurs. 2012 Jun;27(3):248-55. doi: 10.1016/j.pedn.2011.01.032. Epub 2011 Mar 15.
- Individual participant dataSharing planned: No
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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.
Russell J Merritt, MD, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome and Intestinal Failure, run by Children's Hospital Los Angeles 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 7 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrospective data (time frame: up to 1 year). 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 NCT01946503, which also lists 10 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 21 Sep 2023.