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OpenTrials
Completed

NCT Number: NCT04184648

Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) 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(High Flow Nasal Cannula Oxygen) and other NIV(Non-Invasive Ventilation) 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(National Institute of Child Health and Human Development) 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No interventions

Other

no intervention

Primary outcomes

  1. Respiratory Adverse Outcomes

    Time frame: up to 18 months after birth

    Respiratory adverse outcomes include all types of neonatal lung diseases

Secondary outcomes

  1. Growth Restriction

    Time frame: up to PMA 18-24 months

    height, weight or head circumference <3rd percentile for corrected gestational age and sex, growth percentiles defined using the World Health Organization Child Growth Standards

  2. Days of Oxygen Supplement

    Time frame: up to 18 months after birth

    days during which the infants were given oxygen supplement

  3. Physical Development Outcome

    Time frame: up to 18 months after birth

    including length, weight, head circumference

Other outcomes

  1. Follow-up of Neurological Development

    Time frame: up to 18 months after birth

    severe neurological outcomes defined as brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score <85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist;

Sponsors and collaborators

Lead sponsor

Wang Jianhui

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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