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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no interventions | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Adverse Outcomes | Respiratory adverse outcomes include all types of neonatal lung diseases | up to 18 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Restriction | height, weight or head circumference <3rd percentile for corrected gestational age and sex, growth percentiles defined using the World Health Organization Child Growth Standards | up to PMA 18-24 months |
| Days of Oxygen Supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up of Neurological Development | 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; | up to 18 months after birth |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Shi, M.D | Children's Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25762933 | Background | 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. | |
| 3174313 | 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. |
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Infants with severe congenital malformations or missing key study data were excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | No BPD(2018) | Breathing in room air at 36 weeks PMA |
| FG001 | BPD at 36 Weeks(2018) | Need for extra oxygen with any form of ventilatory support at 36 weeks PMA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 270 cases were included in the baseline data and divided into two groups based on whether they were diagnosed with BPD or not in 2018 Definition
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| ID | Title | Description |
|---|---|---|
| BG000 | No BPD | Breathing in room air at 36 weeks PMA |
| BG001 | BPD in 2018 Definition | Need for oxygen with any form of ventilatory support at 36 weeks PMA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Adverse Outcomes | Respiratory adverse outcomes include all types of neonatal lung diseases | Total number of infants with complete follow-up | Posted | Count of Participants | Participants | up to 18 months after birth |
|
The follow-up time was 18-24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurological Disease in High Risk Infants(+)in NO BPD | No BPD but 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebral palsy | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| no sponsor, PI: Yuan Shi | CHCMU | 13508320283 | shiyuan@hospital.cqmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2022 | Aug 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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days during which the infants were given oxygen supplement
| up to 18 months after birth |
| Physical Development Outcome | including length, weight, head circumference | up to 18 months after birth |
| 26397992 | 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. |
| 28196293 | 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. |
| 29790784 | 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. |
| 29551318 | 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. |
| 30995069 | 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. |
| 26283781 | 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. |
| 30966839 | 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. |
| 27853329 | 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. |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Birth weight | Mean | Standard Deviation | grams |
|
| Cesarean section | Count of Participants | Participants |
|
| Prenatal glucocorticosteroids administration | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Growth Restriction | height, weight or head circumference <3rd percentile for corrected gestational age and sex, growth percentiles defined using the World Health Organization Child Growth Standards | Posted | Count of Participants | Participants | up to PMA 18-24 months |
|
|
|
| Secondary | Days of Oxygen Supplement | days during which the infants were given oxygen supplement | Not Posted | up to 18 months after birth | Participants |
| Secondary | Physical Development Outcome | including length, weight, head circumference | Not Posted | up to 18 months after birth | Participants |
| Other Pre-specified | Follow-up of Neurological Development | 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; | Posted | Count of Participants | Participants | up to 18 months after birth |
|
|
|
| Post-Hoc | Oxygen Way | Changes in assisted ventilation | Not Posted | up to 18 months after birth | Participants |
| 5 |
| 130 |
| 5 |
| 130 |
| 3 |
| 130 |
| EG001 | Neurological Disease in High Risk Infants(+)in 2018 BPD | In BPD group and 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 | 14 | 140 | 11 | 140 | 7 | 140 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |