Necrotizing EnterocolitisNCT04921696
Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
An observational study of Necrotizing Enterocolitis and Anemia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Necrotizing Enterocolitis, Anemia, Red Blood Cell (RBC) Transfusion
- What is being tested?
- RBC transfusion and no-RBC transfusion
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2026
- 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
- No healthy volunteers
- Child
Study population: The level of blood bilirubin of the included neonatal infants reached the cirteria of transfusion therapy. Whether or not the transfusion therapy was dicided according to the parents' decision.
Who may be able to join
- age between 1 min and 28 days
- the level blood bilirubin reached the criteria of transfusion therapy
Who cannot join
- congenital abnormalities
- receipt of transfusion before enrollment
- parents' decision not to participate
- infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist
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
Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 [95% confidence interval, 1.6-2.5]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.
Read the detailed description
Improving understanding of the role of RBC transfusion and anemia in the development of NEC is important. Several studies characterizing the associations between transfusion, anemia, and NEC were potentially limited by small sample size, study design. As such, researchers have underscored the need for prospective study in which each RBC exposure, episode of anemia, and outcome of NEC can be systematically and consistently evaluated.
This prospective study examined whether RBC transfusion and anemia were associated with the rate of NEC. The primary objective was to test whether NEC was increased in infants receiving RBC transfusion compared with non transfused infants. Further, exposure to severe neonatal anemia was examined as an independent risk factor for NEC.
- Being tested
- RBC transfusion, no-RBC transfusion
- Keywords
- necrotizing enterocolitis, anemia, red blood cell (RBC) transfusion
- Medical subject headings
- Enterocolitis, Necrotizing, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBC transfusionOther
RBC was transfused to the infants.
no-RBC transfusionOther
RBC was not transfused to the infants.
| Study group | Role | What they receive |
|---|---|---|
| RBC transfusion | RBC was transfused to the infants. Receives: Other: RBC transfusion | |
| no-RBC transfusion | RBC was not transfused to the infants. Receives: Other: no-RBC transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotizing enterocolitis
Necrotizing enterocolitis was diagnosed within 28 days
Measured: within 28 days
Secondary outcomes (1)
death
the infant died
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: no patients were included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies 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
- NCT04921696
- Sponsor's protocol ID
- NECandRBC
- Status last verified
- Oct 2022
- First submitted
- 6 Jun 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
- Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT04921696
- Acronym / sponsor ID
- NECandRBC
- Keywords
- necrotizing enterocolitis, anemia, red blood cell (RBC) transfusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patients 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 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 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.
Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 [95% confidence interval, 1.6-2.5]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.
Detailed description
Improving understanding of the role of RBC transfusion and anemia in the development of NEC is important. Several studies characterizing the associations between transfusion, anemia, and NEC were potentially limited by small sample size, study design. As such, researchers have underscored the need for prospective study in which each RBC exposure, episode of anemia, and outcome of NEC can be systematically and consistently evaluated.
This prospective study examined whether RBC transfusion and anemia were associated with the rate of NEC. The primary objective was to test whether NEC was increased in infants receiving RBC transfusion compared with non transfused infants. Further, exposure to severe neonatal anemia was examined as an independent risk factor for NEC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBC transfusion | – | Other: RBC transfusionRBC was transfused to the infants. |
| no-RBC transfusion | – | Other: no-RBC transfusionRBC was not transfused to the infants. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The level of blood bilirubin of the included neonatal infants reached the cirteria of transfusion therapy. Whether or not the transfusion therapy was dicided according to the parents' decision.
Key inclusion criteria (2 listed)
- age between 1 min and 28 days
- the level blood bilirubin reached the criteria of transfusion therapy
Key exclusion criteria (4 listed)
- congenital abnormalities
- receipt of transfusion before enrollment
- parents' decision not to participate
- infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist
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 |
|---|---|---|
| RBC transfusionRBC was transfused to the infants. | Other | RBC transfusion |
| no-RBC transfusionRBC was not transfused to the infants. | Other | no-RBC transfusion |
Primary outcome
Necrotizing enterocolitis
Time frame: within 28 days
Necrotizing enterocolitis was diagnosed within 28 days
1 secondary outcome
death
Time frame: within 28 days
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 Necrotizing Enterocolitis and Anemia, 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 2 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: 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?
Necrotizing enterocolitis (time frame: within 28 days). 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.