A Phase 2 interventional study of OHB-607 in Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity and Intraventricular Hemorrhage, sponsored by OHB Neonatology Ltd.. Active, not recruiting at 62 sites in 13 countries. Open to participants aged 0 Hours to 24 Hours. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by OHB Neonatology Ltd. · Phase 2, Interventional, and Prevention
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.
Exclusion Criteria:
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Drug: OHB-607
Standard neonatal care alone will be provided.
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Also known as: Mecasermin Rinfabate
Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (±3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
Severe BPD is defined by the modified NICHD severity grading
Time frame: Baseline through 36 weeks postmenstrual age (PMA)
Reducing the burden of Chronic Lung Disease, as indicated by a reduction in time to final weaning off of Respiratory Technology Support (RTS) through 12 months Corrected Age (CA), as compared to the SNC group.
The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS.
Time frame: Baseline through 12 months CA
Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
Severe BPD is defined based on the classification according to Jensen et al., 2019
Time frame: Time Frame: Baseline through 36 weeks postmenstrual age (PMA)
Occurrence of severe (Grade 3 and 4) intraventricular hemorrhage (IVH) before 40 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group
Severe IVH as classified according to the Volpe criteria
Time frame: Baseline through 40 weeks postmenstrual age (PMA)
To assess the effect of OHB-607 on occurrence of severe retinopathy of prematurity (ROP) (Stage 3 and above) up to 40 weeks PMA as compared to the SNC group
Time frame: Baseline through 40 weeks postmenstrual age (PMA)
To assess the effect of OHB-607 on chronic respiratory outcomes as measured by the Chronic Lung Disease Prematurity Severity Score (CLDPSS) as compared to the SNC group at 12 months CA.
Time frame: Baseline until 12 months CA using CLDPSS
The effect of OHB-607 on neurodevelopment is measured by the Cognitive, Language and Motor Scales of the Bayley Scales of Infant and Toddler Development (BSID) III as compared to the SNC group at 24 months CA.
Time frame: Time Frame: Determined by the separate BSID III scales at 24 months CA
Chronic respiratory morbidity outcomes at 24 months CA
Time frame: 24 months CA
Incidence and severity of BPD
BPD severity is defined by the modified NICHD severity grading
Time frame: Baseline through 36 weeks postmenstrual age (PMA)
Jensen BPD grade at 36 weeks PMA (± 3 days), as classified according to Jensen et al., 2019. Incidence of all severity grades of BPD as assessed by Jensen et al., 2019
Time frame: 36 weeks weeks postmenstrual age (PMA) (± 3 days)
Incidence and severity of IVH
Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria
Time frame: Baseline through 36 weeks postmenstrual age (PMA)
Neurodevelopment outcomes
Neurodevelopmental impairment, Physical and cognitive development will be measured by ASQ®-3 administered at 12 and 24 months CA.
Time frame: From 6 months CA through 24 months CA
Incidence of Retinopathy of Prematurity (ROP)
ROP is classified according to the International Classification
Time frame: Baseline through 40 weeks PMA
Mortality from randomization through to 24 months CA
Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA.
Time frame: From birth through 24 months CA
Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)
Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of BPD
Time frame: Baseline through 36 weeks PMA
Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)
Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of IVH
Time frame: Baseline through 40 weeks PMA
Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC)
Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of NEC
Time frame: Baseline through 40 weeks PMA
Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)
Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of ROP
Time frame: Baseline through 40 weeks PMA
To assess the safety profile of OHB-607 as compared to the SNC group.
Incidence, severity, and causality assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs), including Fatal AEs as per the neonatal adverse event severity scale.
Time frame: Baseline through 24 months CA
Plan to share: No — De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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