Survey on the Clinical Use of Recombinant Human Erythropoietin in VLBW and ELBW Infants (NSEPO)

May 11, 2022 updated by: Shenzhen People's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China

Description

Inclusion Criteria:

neonatologists and pediatricians from general hospitals, maternity and infant hospitals, and children's hospitals across China

Exclusion Criteria:

neonatologists and pediatricians from same hospitals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General hospital group
Questionnaires collected from general hospitals in China
Other: not use of any intervention
not use of any intervention
Maternity and infant hospital group
Questionnaires collected from Maternity and infant hospitals in China
Other: not use of any intervention
not use of any intervention
Children's hospital
Questionnaires collected from Children's hospitals in China
Other: not use of any intervention
not use of any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The survey (the clinical use of rhEPO)
Time Frame: 01-june-2022
the clinical use of rhEPO in VLBW and ELBW infants
01-june-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Shenzhen NICUs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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