Intestinal PerforationNCT01530828
IRT in Infants With Intestinal Perforation
An observational study of Intestinal Perforation and Necrotizing Enterocolitis, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. Read more about this study
- Who is it for?
- Ages 1 day to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Intestinal Perforation, Necrotizing Enterocolitis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2014
- 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 1 day to 16 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infants less than 1000 grams, age 1-16 days
Who may be able to join
- Informed consent
- Birth weight less than 1000 grams
- Admitted to investigative site within first 16 days of life.
Who cannot join
- Evidence of Intestinal perforation in utero
- Suspected or confirmed custic fibrosis
- Abdominal wall defect or intestinal atresia
- Concomitant medical condition that may create an unacceptable risk.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospitals & Clinics of Minnesota
Saint Paul, Minnesota, 55102
Pat A Meyers, BS, 651-220-6026, pat.meyers@childrensmn.org
Mark Bergeron, MD
About this study
Official title: Immunoreactive Trypsinogen in Infants With Intestinal Perforation
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.
Read the detailed description
At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.
- Conditions
- Intestinal Perforation, Necrotizing Enterocolitis
- Keywords
- Immunoreactive Trypsinogen, Nectrotizing Enterocolitis, Premature Infants, Serial IRT
- Medical subject headings
- Intestinal Perforation, Enterocolitis, Necrotizing, Premature Birth
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 |
|---|---|---|
| Premature infants | Weight less than 1000 grams, age 1 - 16 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
Measured: 3 years
Secondary outcomes (1)
Determine if factors other than intestinal perforation affect serum IRT.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startAug 2010
- Primary completionSep 2013 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PerforationStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Birge, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530828
- Sponsor's protocol ID
- SPOT IRT
- Status last verified
- Aug 2013
- First submitted
- 8 Feb 2012
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoreactive Trypsinogen in Infants With Intestinal Perforation
- ClinicalTrials.gov ID
- NCT01530828
- Acronym / sponsor ID
- SPOT IRT
- Conditions
- Intestinal Perforation, Necrotizing Enterocolitis
- Keywords
- Immunoreactive Trypsinogen, Nectrotizing Enterocolitis, Premature Infants, Serial IRT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 10 Feb 2012 (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 study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.
Detailed description
At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infants | – | –Weight less than 1000 grams, age 1 - 16 days. |
Who may qualify
- Ages
- 1 day to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infants less than 1000 grams, age 1-16 days
Key inclusion criteria (3 listed)
- Informed consent
- Birth weight less than 1000 grams
- Admitted to investigative site within first 16 days of life.
Key exclusion criteria (4 listed)
- Evidence of Intestinal perforation in utero
- Suspected or confirmed custic fibrosis
- Abdominal wall defect or intestinal atresia
- Concomitant medical condition that may create an unacceptable risk.
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
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
Time frame: 3 years
1 secondary outcome
Determine if factors other than intestinal perforation affect serum IRT.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
Children's Hospitals & Clinics of Minnesota
Saint Paul, United States
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 Intestinal Perforation and Necrotizing Enterocolitis, run by Children's Hospitals and Clinics of Minnesota 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 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 9 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation. (time frame: 3 years). 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 9 Aug 2013.