Erythropoietin; Infant; Surveys and QuestionnairesNSEPONCT05372211
Survey on the Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants
An observational study of Erythropoietin; Infant; Surveys and Questionnaires, run by Shenzhen People's Hospital.
Trial summary
Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) and extremly low birth weight (ELBW) infants and has been licensed for this indication in Europe in 1997. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Erythropoietin; Infant; Surveys and Questionnaires
- What is being tested?
- not use of any intervention
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China
Who may be able to join
- neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China
Who cannot join
- neonatologists and pediatricians from same hospitals
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants: a National Survey in China
Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) and extremly low birth weight (ELBW) infants and has been licensed for this indication in Europe in 1997. The objective of the study was to obtain information on the use or nonuse of rhEPO in neonatal units in China.
Read the detailed description
The survey was developed by a team of neonatologists at Shenzhen People's hospital . The survey consisted of 26 questions covering three areas: the characteristics of the survey respondents, the use of rhEPO in VLBW and ELBW infants , and other related questions. The questionnaire was presented in the Questionnaire Star format (https://www.wjx.cn/, Hangzhou Oway Medical Technology,Changsha, China). we plan to conduct a cross-sectional survey through the Neonatal Professional Committee of the Chinese Medical Doctor Association WeChat platform. The questionnaire is going to be distributed to nearly 500 representative neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across the country. Furthermore, this study was approved by the ethics committee of the Shenzhen People's Hospital.
- Being tested
- not use of any intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not use of any interventionOther
not use of any intervention
| Study group | Role | What they receive |
|---|---|---|
| General hospital group | Questionnaires collected from general hospitals in China Receives: Other: not use of any intervention | |
| Maternity and infant hospital group | Questionnaires collected from Maternity and infant hospitals in China Receives: Other: not use of any intervention | |
| Children's hospital | Questionnaires collected from Children's hospitals in China Receives: Other: not use of any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survey (the clinical use of rhEPO)
the clinical use of rhEPO in VLBW and ELBW infants
Measured: 01-june-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythropoietin; Infant; Surveys and QuestionnairesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372211
- Sponsor's protocol ID
- Shenzhen NICUs
- Acronym
- NSEPO
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants: a National Survey in China
- ClinicalTrials.gov ID
- NCT05372211
- Acronym / sponsor ID
- NSEPO / Shenzhen NICUs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 12 May 2022 (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.
Recombinant human erythropoietin (rhEPO) has been shown to effectively and safely prevent the anemia of prematurity and to reduce the transfusion need in very low birth weight (VLBW) and extremly low birth weight (ELBW) infants and has been licensed for this indication in Europe in 1997. The objective of the study was to obtain information on the use or nonuse of rhEPO in neonatal units in China.
Detailed description
The survey was developed by a team of neonatologists at Shenzhen People's hospital . The survey consisted of 26 questions covering three areas: the characteristics of the survey respondents, the use of rhEPO in VLBW and ELBW infants , and other related questions. The questionnaire was presented in the Questionnaire Star format (https://www.wjx.cn/, Hangzhou Oway Medical Technology,Changsha, China). we plan to conduct a cross-sectional survey through the Neonatal Professional Committee of the Chinese Medical Doctor Association WeChat platform. The questionnaire is going to be distributed to nearly 500 representative neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across the country. Furthermore, this study was approved by the ethics committee of the Shenzhen People's Hospital.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General hospital group | – | Other: not use of any interventionQuestionnaires collected from general hospitals in China |
| Maternity and infant hospital group | – | Other: not use of any interventionQuestionnaires collected from Maternity and infant hospitals in China |
| Children's hospital | – | Other: not use of any interventionQuestionnaires collected from Children's hospitals in China |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China
Key inclusion criteria (1 listed)
- neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China
Key exclusion criteria (1 listed)
- neonatologists and pediatricians from same hospitals
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 |
|---|---|---|
| not use of any interventionnot use of any intervention | Other | Children's hospital, General hospital group, Maternity and infant hospital group |
Primary outcome
The survey (the clinical use of rhEPO)
Time frame: 01-june-2022
the clinical use of rhEPO in VLBW and ELBW infants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythropoietin; Infant; Surveys and Questionnaires, run by Shenzhen People's Hospital.
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 1 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhangbin Yu, Doctor (+86 13913994139, yuzhangbin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survey (the clinical use of rhEPO) (time frame: 01-june-2022). 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 12 May 2022.