Comparison of Classification Standards of BPD in Premature Infants

Brief Title

Comparison of Classification Standards of BPD in Premature Infants

Official Title

Clinical Study on Comparative Diagnostic Criteria of Bronchopulmonary Dysplasia in Premature Infants

Brief Summary

      Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature
      infants. Long-term complications such as recurrent respiratory infection and abnormal lung
      function may occur in the survivors, and may increase the risk of dysplasia of the nervous
      system. In the past 30 years, although the monitoring and treatment technology of premature
      infants has been significantly improved, the incidence of BPD still shows no downward trend,
      and effective treatment and prevention methods for BPD are still lacking. The progress of
      clinical research on BPD is slow, one of the important reasons is that the definition of BPD
      is still not consistent, and its diagnostic and grading standards lack objectivity. To
      summarize the development of diagnostic criteria for BPD in the past 30 years, there are
      still the following disadvantages. 1. 2. In the above study, all proposed alternative BPD
      classification standards did not completely separate HFNC and NIV. In view of this, this
      study separated HFNC and other NIV to form a new revised BPD classification standard. On this
      basis, a nested case-control study was conducted to compare the differences between the newly
      proposed classification standards and NICHD standards in 2001, Rosemary standards in 2018 and
      Jensen standards in predicting long-term respiratory outcomes and other systemic
      complications in premature infants, so as to provide a standard for more accurate diagnosis
      and evaluation of BPD in premature infants.
    

Study Type

Observational

Primary Outcome

mortality

Secondary Outcome

 Length of first hospital stay

Condition

Bronchopulmonary Dysplasia

Intervention

no interventions

Study Arms / Comparison Groups

 There was no adverse systems outcome after PMA36 weeks

Description:  Premature infants at PMA36 weeks did not show the following conditions (1) before follow-up tracheotomy; (2) the duration of hospital stay exceeds 50 weeks of PMA; (3) continuous or intermittent use of oxygen and respiratory support for more than 12 months after birth; (4) readmission ≥2 times due to respiratory factors within 12 months. (5) death

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

200

Start Date

June 1, 2020

Completion Date

June 29, 2022

Primary Completion Date

June 20, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  premature infants whose gestational age is less than 32 weeks;

          -  hospital stay ≥14 days;

          -  complete clinical medical records, including effective follow-up information

        Exclusion Criteria:

          -  congenital heart and lung malformation and specific chromosomal diseases;

          -  children abandon treatment halfway;

          -  death of children due to factors other than respiratory system.
      

Gender

All

Ages

N/A - 32 Weeks

Accepts Healthy Volunteers

No

Contacts

Yuan Shi, M.D, , 

Location Countries

China

Location Countries

China

NCT ID

NCT04184648

Organization ID

00020191112

Responsible Party

Sponsor-Investigator

Study Sponsor

Wang Jianhui

Study Sponsor

Yuan Shi, M.D, Study Director, Children's Hospital of Chongqing Medical University

Verification Date

November 2020