Clinical trial NCT04237844: Clinic Features and Outcome of BPD (SGBPD)
Official title: Clinic Features and Long-term Outcome of Different Subgroups of Brochopulmonary Dysplasia in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature infants born at \<32 weeks of gestational age and the hospitalization time ≥ 14 days.

Brief summary: This study described the perinatal high-risk factors and clinical manifestations of the children, and compared the high-risk factors, clinical manifestations and prognosis of BPD among different clinical subtypes by comparison between groups. BPD grading was performed using the 2018 grading standard to compare the distribution of I/II/III BPD among different groups.


Eligibility criteria: Inclusion Criteria:

1. Premature infants born at \<32 weeks of gestational age;
2. hospitalization time ≥ 14 days;
3. The clinical medical records are complete

Exclusion Criteria:

* • 1) Children with congenital heart, lung malformation and definite chromosomal diseases; 2) children gave up treatment halfway; 3) corrected gestational age 36 weeks before death, the cause of death was confirmed as factors other than respiratory system.

Primary outcomes:
measure: Mortality
timeFrame: up to 12 months after birth
measure: Serious respiratory mobidities
timeFrame: up to 18 months after birth
measure: Duration of first hospital stay
timeFrame: up to 12 months after birth
measure: Days with oxygen supplement
timeFrame: up to 12 months after birth
measure: Days of Mechanical Ventilation
timeFrame: up to 12 months after birth
Secondary outcomes:
measure: weight
timeFrame: up to 18months after birth
measure: length
timeFrame: up to 18months after birth
measure: head circumference
timeFrame: up to 18months after birth
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: children's hospital of chongqiong Medical University
name: Yuan Shi
role: STUDY_DIRECTOR
References:
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citation: Panickar J, Scholefield H, Kumar Y, Pilling DW, Subhedar NV. Atypical chronic lung disease in preterm infants. J Perinat Med. 2004;32(2):162-7. doi: 10.1515/JPM.2004.029.
citation: 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.
citation: Schmidt B. No End to Uncertainty about Inhaled Glucocorticoids in Preterm Infants. N Engl J Med. 2015 Oct 15;373(16):1566-7. doi: 10.1056/NEJMe1509243. No abstract available.
citation: 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.
citation: Steinhorn R, Davis JM, Gopel W, Jobe A, Abman S, Laughon M, Bancalari E, Aschner J, Ballard R, Greenough A, Storari L, Thomson M, Ariagno RL, Fabbri L, Turner MA; International Neonatal Consortium. Chronic Pulmonary Insufficiency of Prematurity: Developing Optimal Endpoints for Drug Development. J Pediatr. 2017 Dec;191:15-21.e1. doi: 10.1016/j.jpeds.2017.08.006. No abstract available.