Comparison of Classification Standards of BPD in Premature Infants

NCT ID: NCT04184648

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-06-29

Brief Summary

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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 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.

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

no interventions

Intervention Type OTHER

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

no interventions

Intervention Type OTHER

no intervention

Interventions

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no interventions

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wang Jianhui

OTHER

Sponsor Role lead

Responsible Party

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Wang Jianhui

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yuan Shi, M.D

Role: STUDY_DIRECTOR

Children's Hospital of Chongqing Medical University

Locations

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Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 25762933 (View on PubMed)

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.

Reference Type RESULT
PMID: 3174313 (View on PubMed)

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.

Reference Type RESULT
PMID: 26397992 (View on PubMed)

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.

Reference Type RESULT
PMID: 28196293 (View on PubMed)

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.

Reference Type RESULT
PMID: 29790784 (View on PubMed)

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.

Reference Type RESULT
PMID: 29551318 (View on PubMed)

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.

Reference Type RESULT
PMID: 30995069 (View on PubMed)

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.

Reference Type RESULT
PMID: 26283781 (View on PubMed)

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.

Reference Type RESULT
PMID: 30966839 (View on PubMed)

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.

Reference Type RESULT
PMID: 27853329 (View on PubMed)

Other Identifiers

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00020191112

Identifier Type: -

Identifier Source: org_study_id

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