Analysis of BPD in Premature Infants With Typical Imaging Changes

Status Completed

Clinical Trial Summary

Bronchopulmonary dysplasia (BPD) is a common chronic respiratory disease in preterm infants. The increase in the survival rate of premature babies following the improvement of perinatal treatment and care has caused an increase in the incidence of BPD in recent years, which has seriously affected the quality of life of preterm infants. According to the consensus reached at the workshop sponsored by the National Institute of Child Health and Human Development (NICHD) in 2001, BPD was clinically defined based on oxygen dependency in preterm infants. However, the refined NICHD definition of BPD in 2018 emphasizes imaging findings to support a diagnosis of lung parenchyma disease. Fibrotic opacities and cystic changes on chest imaging (chest X-ray [CXR] or computed tomography [CT] scan) were considered typical findings in BPD patients. In patients with severe BPD, the presence of bubbles/cystic appearance on CXR after 28 days of life was reported to be an important factor, and typical imaging findings can predict a poor pulmonary outcome in BPD patients. BPD is associated with poor outcomes. Although many studies have been conducted on BPD, there are limited reports specifically evaluating the association of typical imaging findings with clinical characteristics and later outcomes in patients with BPD. We hypothesized that BPD with typical imaging findings was likely to be a particular subgroup of this entity, with a unique etiology, clinical characteristics and prognosis. Therefore, this retrospective study aimed to compare clinical characteristics, short-term outcomes and follow-up data until 2 years of age in preterm infants with or without typical imaging findings of BPD on CXR or CT scan during the entire hospital stay. A propensity score analysis was used to reduce bias between the two groups, and multivariate logistic regression analysis was performed to identify factors related to mortality in preterm infants with BPD.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Bronchopulmonary Dysplasia

Clinical Trial Details

NCT number	NCT04163822
Study type	Observational
Source	Children's Hospital of Chongqing Medical University
Contact
Status	Completed
Phase
Start date	January 1, 2020
Completion date	May 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04506619` - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed	`NCT04936477` - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants	N/A
Recruiting	`NCT05285345` - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT02249143` - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants	N/A
Active, not recruiting	`NCT01632475` - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT00419588` - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Completed	`NCT00319956` - Trial II of Lung Protection With Azithromycin in the Preterm Infant	Phase 2
Completed	`NCT00208039` - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates	N/A
Completed	`NCT00006401` - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants	Phase 3
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00006058` - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
Completed	`NCT05152316` - The Baby Lung Study
Recruiting	`NCT04821453` - NAVA vs. CMV Crossover in Severe BPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.