Pulmonary inflammation and glucocorticoid sensitivity for the prediction of bronchopulmonary dysplasia (PRIDICT-BPD): A multicenter study

Recruiting

• Conditions: 10028971; Bronchopulmonary dysplasia; chronic lung disease of prematurity

• Registration Number: NL-OMON50974
• Lead Sponsor: Amsterdam Universitair Medische Centra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 375

Inclusion Criteria

Newborn infant born <30 weeks of gestation

Exclusion Criteria

Major congenital anomalies, such as congenital heart and pulmonary defects, and
major genetic anomalies.
Major surgery in the first 24 hours after birth

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters:<br /><br>1. Pulmonary inflammation, as assessed from volatile organic compounds (VOCs);<br /><br>2. Adrenocortical output, as assessed from levels of cortisol, 17-OH<br /><br>progesterone and 11-deoxycortisol;<br /><br>3. Glucocorticoid tissue-sensitivity, as assessed from single-nucleotide<br /><br>polymorphisms (SNPs) in the glucocorticoid receptor gene and<br /><br>glucocorticoid-responsive genes involved in lung development.<br /><br><br /><br>Primary outcome:<br /><br>The occurrence and severity of BPD.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome:<br /><br>Neurocognitive development at 1 and 2 years of corrected age, as assessed from<br /><br>eye tracking at the age (if available in participating center) and the Bayley<br /><br>Scales of Infant Development, respectively.</p><br>