Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants

NCT04184648 | Completed Results

• 1 other identifier: 00020191112
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

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(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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia; high-flow nasal cannula; noninvasive ventilation; Ventilation mode; premature infant

Outcome Measures

Primary Outcomes (1)

• Respiratory Adverse Outcomes

  Respiratory adverse outcomes include all types of neonatal lung diseases

  up to 18 months after birth

Secondary Outcomes (3)

• Growth Restriction

  up to PMA 18-24 months

• Days of Oxygen Supplement

  up to 18 months after birth

• Physical Development Outcome

  up to 18 months after birth

Other Outcomes (1)

• Follow-up of Neurological Development

  up to 18 months after birth

Study Arms (2)

There was no adverse systems outcome after PMA36 weeks

Premature infants at PMA（postmenstrual age）36 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

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

Interventions

no interventions OTHER

no intervention

Death or adverse respiratory outcome after 36 weeks of pma; There was no adverse systems outcome after PMA36 weeks

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• premature infants whose gestational age is less than 32 weeks;
• hospital stay ≥14 days;
• complete clinical medical records, including effective follow-up information

You may not qualify if:

• congenital heart and lung malformation and specific chromosomal diseases;
• children abandon treatment halfway;
• death of children due to factors other than respiratory system.

Sponsors & Collaborators

• Wang Jianhui: lead

Study Sites (1)

Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

Related Publications (10)

• Iyengar A, Davis JM. Drug therapy for the prevention and treatment of bronchopulmonary dysplasia. Front Pharmacol. 2015 Feb 16;6:12. doi: 10.3389/fphar.2015.00012. eCollection 2015.

  PMID: 25762933 BACKGROUND

• Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.

  PMID: 3174313 BACKGROUND

• Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.

  PMID: 26397992 BACKGROUND

• Meyer S, Franz AR, Bay J, Gortner L; NeoVitaA Study Group. Developing a better and practical definition of bronchopulmonary dysplasia. Acta Paediatr. 2017 May;106(5):842. doi: 10.1111/apa.13783. Epub 2017 Mar 13. No abstract available.

  PMID: 28196293 BACKGROUND

• Higano NS, Spielberg DR, Fleck RJ, Schapiro AH, Walkup LL, Hahn AD, Tkach JA, Kingma PS, Merhar SL, Fain SB, Woods JC. Neonatal Pulmonary Magnetic Resonance Imaging of Bronchopulmonary Dysplasia Predicts Short-Term Clinical Outcomes. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1302-1311. doi: 10.1164/rccm.201711-2287OC.

  PMID: 29790784 BACKGROUND

• Higgins RD, Jobe AH, Koso-Thomas M, Bancalari E, Viscardi RM, Hartert TV, Ryan RM, Kallapur SG, Steinhorn RH, Konduri GG, Davis SD, Thebaud B, Clyman RI, Collaco JM, Martin CR, Woods JC, Finer NN, Raju TNK. Bronchopulmonary Dysplasia: Executive Summary of a Workshop. J Pediatr. 2018 Jun;197:300-308. doi: 10.1016/j.jpeds.2018.01.043. Epub 2018 Mar 16. No abstract available.

  PMID: 29551318 BACKGROUND

• Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.

  PMID: 30995069 BACKGROUND

• Kotecha SJ, Adappa R, Gupta N, Watkins WJ, Kotecha S, Chakraborty M. Safety and Efficacy of High-Flow Nasal Cannula Therapy in Preterm Infants: A Meta-analysis. Pediatrics. 2015 Sep;136(3):542-53. doi: 10.1542/peds.2015-0738. Epub 2015 Aug 17.

  PMID: 26283781 BACKGROUND

• Hong H, Li XX, Li J, Zhang ZQ. High-flow nasal cannula versus nasal continuous positive airway pressure for respiratory support in preterm infants: a meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2021 Jan;34(2):259-266. doi: 10.1080/14767058.2019.1606193. Epub 2019 Apr 24.

  PMID: 30966839 BACKGROUND

• Kadivar M Md, Mosayebi Z Md, Razi N Md, Nariman S Md, Sangsari R Md. High Flow Nasal Cannulae versus Nasal Continuous Positive Airway Pressure in Neonates with Respiratory Distress Syndrome Managed with INSURE Method: A Randomized Clinical Trial. Iran J Med Sci. 2016 Nov;41(6):494-500.

  PMID: 27853329 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: no sponsor, PI: Yuan Shi
• Organization: CHCMU

shiyuan@hospital.cqmu.edu.cn

13508320283

Study Officials

• Yuan Shi, M.D

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: June 1, 2020
• Primary Completion: June 20, 2022
• Study Completion: July 29, 2022
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-03

Locations

CN (1)