EnterostomyNCT02812095
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
A study testing Refeeding in people with Enterostomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Read more about this study
- Who is it for?
- Ages Up to 35 weeks
- Conditions the study is for
- Enterostomy
- What is being tested?
- Refeeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to 16 Apr 2020
- 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 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy
Who cannot join
- Congenital gastrointestinal malformation
- Blind pouch (after laparotomy)
- Refeeding procedure related infection
- Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)
Trial locations and contacts
1 site in 1 country.
About this study
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.
- Conditions
- Enterostomy
- Being tested
- Refeeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RefeedingProcedure or surgery
Also called extracorporeal stool transport
when amount of feeding reach to 120mL/kg a day,
| Study group | Role | What they receive |
|---|---|---|
| The refeeding group | Experimental | Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation. Receives: Procedure: Refeeding |
| The control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of citrulline level during the study period
4 time points: at the time of full enteral feeding (>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation
Measured: up to 6 months of corrected age
Secondary outcomes (4)
The pathologic findings after refeeding procedure
villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation
Measured: up to 8 weeks of corrected age
the number of days on parenteral nutrition
the day of discontinuation of intravenous protein supplements
Measured: up to 8 weeks of corrected age
The weight gain
differences in the admission weight Z-scores and end of study weight Z-scores
Measured: up to 6 months of corrected age
Adverse events during refeeding procedure
bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma
Measured: up to 8 weeks of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2014
- Primary completion11 Dec 2019
- Study completion16 Apr 2020
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 EnterostomyStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ee-Kyung Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812095
- Sponsor's protocol ID
- 1407-193-601
- Status last verified
- Mar 2021
- First submitted
- 6 Jun 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Lee ES, Kim EK, Shin SH, Jung YH, Song IG, Kim YJ, Kim HY, Choi YH, Moon KC, Kim B. Efficacy and safety of mucous fistula refeeding in preterm infants: an exploratory randomized controlled trial. BMC Pediatr. 2023 Mar 29;23(1):137. doi: 10.1186/s12887-023-03950-1.
PubMed 36991415
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
- ClinicalTrials.gov ID
- NCT02812095
- Acronym / sponsor ID
- 1407-193-601
- Conditions
- Enterostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 24 Jun 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.
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The refeeding group | Experimental | Procedure: RefeedingRefeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation. |
| The control group | No intervention | – |
Who may qualify
- Ages
- Up to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy
Key exclusion criteria (4 listed)
- Congenital gastrointestinal malformation
- Blind pouch (after laparotomy)
- Refeeding procedure related infection
- Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)
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 |
|---|---|---|
| RefeedingAlso: extracorporeal stool transportwhen amount of feeding reach to 120mL/kg a day, | Procedure or surgery | The refeeding group |
Primary outcome
The change of citrulline level during the study period
Time frame: up to 6 months of corrected age
4 time points: at the time of full enteral feeding (>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation
4 secondary outcomes
The pathologic findings after refeeding procedure
Time frame: up to 8 weeks of corrected age
the number of days on parenteral nutrition
Time frame: up to 8 weeks of corrected age
The weight gain
Time frame: up to 6 months of corrected age
Adverse events during refeeding procedure
Time frame: up to 8 weeks of corrected age
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 18 Mar 2021.
- Derived from this study: PubMed 36991415Lee ES, Kim EK, Shin SH, Jung YH, Song IG, Kim YJ, Kim HY, Choi YH, Moon KC, Kim B. Efficacy and safety of mucous fistula refeeding in preterm infants: an exploratory randomized controlled trial. BMC Pediatr. 2023 Mar 29;23(1):137. doi: 10.1186/s12887-023-03950-1.
- Individual participant dataSharing planned: Yes
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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 Refeeding in people with Enterostomy, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 18 Mar 2021. 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 South Korea. 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?
The change of citrulline level during the study period (time frame: up to 6 months of corrected age). 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 NCT02812095, 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 18 Mar 2021.