Chronic Lung Disease MedDRA version: 21.1 Level: LLT Classification code 10066204 Term: Chronic lung disease of prematurity System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
OHB Neonatology Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 GA, inclusive. Are the trial subjects under 18? yes Number of subjects for this age range: 338 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Detectable major (or severe) congenital malformation identified before randomization. 2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion. 3. Hypoglycemia at baseline (blood glucose <45 mg/dL or 2.5 mmol/L) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion. 5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the subject or interfere with the subject's potential compliance with this protocol or interfere with interpretation of results. 6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis). 7. The subject or subject's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator. 8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy. Major (or severe) congenital malformations include structurally significant congenital heart disease, and structural abnormalities of the upper airway, lungs or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardiopulmonary development, neurologic development, or interpretation of study results. Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary. Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, subjects with infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded. Inclusion/exclusion will ultimately be determined by the investigator, based on assessment of the clinical presentation of each candidate subject and the likelihood that physical finding(s) are associated with a condition that impacts health and development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD (as defined by the modified NICHD severity grading) at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.;Secondary Objective: •To assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in time to final weaning off of RTS through 12 months CA, as compared to the SNC group •To assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of Grade 2 and Grade 3 (severe) BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group, as classified according to Jensen et al., 2019 •To assess the effect of OHB-607 on the occurrence of severe (Grade 3 and 4) IVH before 40 weeks PMA, as assessed by CUS as compared to the SNC group •To assess the effect of OHB-607 on occurrence of severe ROP (Stage 3 and above) up to 40 weeks PMA as compared to the SNC group •To assess the effect of OHB-607 on chronic respiratory outcomes as measured by the CLDPSS as compared to the SNC group at 12 months CA Refer to protocol for full list of secondary objectives;Primary end point(s): Incidence of severe BPD (as defined by the modified NICHD severity grading) or death for all subjects at or before 36 weeks (±3 days) 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% and/or any positive pressure ventilation (CPAP, IMV, NNIMV, or high flow nasal cannula =2 L/min) at 36 weeks PMA.;Timepoint(s) of evaluation of this end point: At 36 weeks PMA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to final weaning off of RTS from Day 1 of randomization through 12 months CA. The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS. • Incidence of Grade 2 and Grade 3 (severe) BPD (as defined by the modified Jensen severity grading) or death for all subjects at 36 weeks PMA. The definitions for BPD are based on the classification according to Jensen et al., 2019: - No BPD: no support. - Grade 1: supplemental oxygen 50% of ventricle with or without periventricular echo densities. - Grade 4: evidence of posthemorrhagic infarction or periventricular echo densities. • Incidence of severe ROP (Stage 3 and above) up to 40 weeks PMA according to International Classification (International Committee for the Classification of Retinopathy of Prematurity, 2021) by local blinded reviewer. • Respiratory severity scoring will be determined from information captured during follow-up telephone calls and clinical site visits at intervals specified until 12 months CA using CLDPSS. • Neurodevelopmental impairment as determined by the separate BSID III scales at 24 months CA. - Motor composite score - Cognitive composite score - Language composite score Refer protocol for other Secondary end points;Timepoint(s) of evaluation of this end point: At 40 weeks PMA and at 12 and 24 months CA. | — |
Countries
Canada, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactCustomer Services
OHB Neonatology Ltd
Outcome results
None listed