Comparison of Classification Standards of BPD in Premature Infants

March 16, 2022 updated by: Wang Jianhui

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Children's Hospital of Chongqing Medical University

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

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All premature infants whose gestational age is less than 32 weeks admitted to the neonatal department of children's hospital of chongqing medical university from January 2018 to May 2019 were in line with this study.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
There was no adverse systems outcome after PMA36 weeks
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
Other: no interventions
no intervention
Death or adverse respiratory outcome after 36 weeks of pma
Premature infants at PMA36 weeks presented the following conditions (1) before tracheotomy during follow-up; (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
Other: no interventions
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: through study completion, an average of 12 months
the proportion of dead BPD infants against the total BPD infants in corresponding group
through study completion, an average of 12 months
serious respiratory mobidities
Time Frame: up to 18 months after birth
occurence of at least one of the following:(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.
up to 18 months after birth
Follow-up of neurological development
Time Frame: up to 18 months after birth
occurence of at least one of the following:(1) TIMP score ≤ reference P25, or bayley-3 cognitive or motor score < 85; (2) abnormal hearing screening or BAEP for two times; (3) abnormal ROP screening
up to 18 months after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of first hospital stay
Time Frame: up to PMA 36 weeks
days
up to PMA 36 weeks
days of oxygen supplement
Time Frame: up to 18 months after birth
days during which the infants were given oxygen supplement
up to 18 months after birth
Pulmonary imaging findings
Time Frame: up to PMA 36 weeks
result of X-ray
up to PMA 36 weeks
Oxygen way
Time Frame: up to 18 months after birth
Changes in assisted ventilation
up to 18 months after birth
physical development outcome
Time Frame: up to 18 months after birth
including length, weight, head circumference
up to 18 months after birth

Collaborators and Investigators

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

Sponsor

Wang Jianhui

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 20, 2022

Study Completion (Anticipated)

June 29, 2022

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00020191112

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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