NCT03253263 - A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants | Crick

Eligibility

Sex: ALLMin age: 0 HoursMax age: 24 Hours

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consents and/or assents must be signed and dated by the participant'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 participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. 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. 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 less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) 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 participant or interfere with the participant'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 participant or participant'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. 9. Birth mother with known HIV or hepatitis (B, C, or E) infection.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Overview

Conditions

Interventions

Eligibility

Locations (72)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts