Bloody StoolNCT05055817
a Clinical Risk Score to Predict Bloody Stool in Neonates
An observational study of Bloody Stool and Necrotizing Enterocolitis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Bloody Stool, Necrotizing Enterocolitis
- What is being tested?
- bloody stool group and non-bloody stool group
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2024
- 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 minute to 28 days
- All sexes
- Child
Study population: neonates with more than or equal to 35 weeks' GA and less than or equal to 28 days in non-neonatal intensive care unit ward are included.
Who may be able to join
- more than or equal to 35 weeks' gestational age(GA)
- less than or equal to 28 days
- non-neonatal intensive care unit ward
Who cannot join
- parents' rejection
- main congenital malformation
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit
Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization.
NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.
Read the detailed description
NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.
Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.
Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.
- Conditions
- Bloody Stool, Necrotizing Enterocolitis
- Being tested
- bloody stool group, non-bloody stool group
- Medical subject headings
- Gastrointestinal Hemorrhage, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bloody stool groupOther
bloody stool appear in the hospitalized neonate
non-bloody stool groupOther
bloody stool do not appear in the hospitalized neonate
| Study group | Role | What they receive |
|---|---|---|
| bloody stool group | bloody stool appear in the hospitalized neonate Receives: Other: bloody stool group | |
| non-bloody stool group | bloody stool do not appear in the hospitalized neonate Receives: Other: non-bloody stool group |
What is being measured
The primary outcome is the main question the study is designed to answer.
a Clinical Risk Score
a Clinical Risk Score is developed in a retrospective cohort
Measured: up to 28 days or discharge from hospital
validation of a Clinical Risk Score
a Clinical Risk Score is validation in another prospective cohort
Measured: up to 28 days or discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: no participants were included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloody StoolStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055817
- Sponsor's protocol ID
- 2020204
- Status last verified
- Oct 2022
- First submitted
- 15 Sep 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05055817
- Acronym / sponsor ID
- 2020204
- Conditions
- Bloody Stool, Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants were included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Sep 2021 (actual)
- 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.
Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization.
NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.
Detailed description
NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.
Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.
Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bloody stool group | – | Other: bloody stool groupbloody stool appear in the hospitalized neonate |
| non-bloody stool group | – | Other: non-bloody stool groupbloody stool do not appear in the hospitalized neonate |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- neonates with more than or equal to 35 weeks' GA and less than or equal to 28 days in non-neonatal intensive care unit ward are included.
Key inclusion criteria (3 listed)
- more than or equal to 35 weeks' gestational age(GA)
- less than or equal to 28 days
- non-neonatal intensive care unit ward
Key exclusion criteria (2 listed)
- parents' rejection
- main congenital malformation
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 |
|---|---|---|
| bloody stool groupbloody stool appear in the hospitalized neonate | Other | bloody stool group |
| non-bloody stool groupbloody stool do not appear in the hospitalized neonate | Other | non-bloody stool group |
Primary outcome
a Clinical Risk Score
Time frame: up to 28 days or discharge from hospital
a Clinical Risk Score is developed in a retrospective cohort
validation of a Clinical Risk Score
Time frame: up to 28 days or discharge from hospital
a Clinical Risk Score is validation in another prospective cohort
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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?
An observational study of Bloody Stool and Necrotizing Enterocolitis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 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: withdrawn, as of the sponsor's last update on 1 May 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 China. 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 withdrawn before enrolling participants, so there are no results.
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?
a Clinical Risk Score (time frame: up to 28 days or discharge from hospital). The study lists 2 primary outcomes in all. 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 1 May 2023.