Comparison of Classification Standards of BPD in Premature Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04184648
• Other study ID #: 00020191112
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: June 29, 2022

Study information

• Verified date: March 2022
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 29, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth

Intervention

Other:
• no interventions
no intervention

Locations

Country	Name	City	State
China	Children's hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Wang Jianhui

Country where clinical trial is conducted

China, 

References & Publications (10)

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 — View 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 — View Citation

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: — View Citation

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. Review. — View Citation

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 R — View Citation

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 M — View Citation

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. Review. — View Citation

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. — View 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 Respi — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	the proportion of dead BPD infants against the total BPD infants in corresponding group	through study completion, an average of 12 months
Primary	serious respiratory mobidities	occurence of at least one of the following:(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.	up to 18 months after birth
Primary	Follow-up of neurological development	occurence of at least one of the following:(1) TIMP score = reference P25, or bayley-3 cognitive or motor score < 85; (2) abnormal hearing screening or BAEP for two times; (3) abnormal ROP screening	up to 18 months after birth
Secondary	Length of first hospital stay	days	up to PMA 36 weeks
Secondary	days of oxygen supplement	days during which the infants were given oxygen supplement	up to 18 months after birth
Secondary	Pulmonary imaging findings	result of X-ray	up to PMA 36 weeks
Secondary	Oxygen way	Changes in assisted ventilation	up to 18 months after birth
Secondary	physical development outcome	including length, weight, head circumference	up to 18 months after birth