A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Phase 2

Conditions: bronchopulmonary dysplasia
Chronic lung disease
10028971

Registration Number: NL-OMON52648

Lead Sponsor: OHB Neonatology Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Written informed consents and/or assents must be signed and dated by the
subject's parent(s) prior to any study-related procedures. The informed consent
and any assents for underage parents must be approved by the IRB/IEC (in
accordance with local regulations).
2. Written informed consents and/or assents must be signed and dated by the
subject's birth mother prior to providing study-related information related to
birth mother medical history, pregnancy and the birth of the subject. The
informed consent and any assents for underage birth mothers must be approved by
the IRB/IEC (in accordance with local regulations).
3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days.

Exclusion Criteria

Incidence of severe BPD (as defined by the modified NICHD severity grading) for
all subjects at 36 weeks PMA. The definitions for BPD are based upon the
modified NICHD guidelines for preterm infants born at <32 weeks GA:
• No BPD: oxygen for <28 days or none.
• Mild BPD: a need for oxygen for >=28 days but on room air at 36 weeks PMA.
• Moderate BPD: oxygen for >=28 days plus treatment with <30% oxygen at 36 weeks
PMA.
• Severe BPD: oxygen for >=28 days plus oxygen >30% or positive pressure, or
high flow nasal cannula >=2 L/minute at 36 weeks PMA.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of severe BPD (as defined by the modified NICHD severity grading) or<br /><br>death for all subjects at or before 36 weeks (±3 days) PMA. The definitions for<br /><br>BPD are based upon the modified NICHD guidelines for preterm infants born at<br /><br><32 weeks GA:<br /><br>• No BPD: oxygen for <28 days or none.<br /><br>• Mild BPD: a need for oxygen for >=28 days but on room air at 36 weeks PMA.<br /><br>• Moderate BPD: oxygen for >=28 days plus treatment with <30% oxygen at 36 weeks<br /><br>PMA.<br /><br>• Severe BPD: oxygen for >=28 days plus oxygen >30% or positive pressure<br /><br>ventilation (CPAP, IMV, NNIMV), or high flow nasal cannula >=2 L/minute at 36<br /><br>weeks PMA.</p><br>

Secondary Outcome Measures