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Trial · Interventional

Active, not recruitingPhase 2Registry data

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

NCTNCT03253263 (opens ClinicalTrials.gov in a new tab)Other idOHB-607-202Other id2018-001393-16Other idjRCT2071200076Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
295 participants (actual)
Sponsor
OHB Neonatology Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
13 countries

United States, Australia, Canada, Finland, Germany, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, United Kingdom

Start
9 May 2019
Primary completion
31 Jul 2026 (estimated)
Completion
21 Jan 2028 (estimated)
First posted
17 Aug 2017
Last update posted
3 Aug 2026
Conditions
Bronchopulmonary Dysplasia · Chronic Lung Disease of Prematurity · Intraventricular Hemorrhage · Retinopathy of Prematurity (ROP)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202022202420262028
  1. Ph 2

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

    NCT03253263

    9 May 2019 to est. 21 Jan 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OHB-607Drug

Arms2

  • Experimental

    OHB-607

    Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.

  • No intervention

    Standard Neonatal Care

    Standard neonatal care alone will be provided.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Time frame · Baseline through 36 weeks postmenstrual age (PMA)

    Registry description

    Severe BPD is defined by the modified NICHD severity grading

Secondary outcomes(18)

  1. 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.

    Time frame · Baseline through 12 months CA

    Registry description

    The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS.

  2. 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.

    Time frame · Time Frame: Baseline through 36 weeks postmenstrual age (PMA)

    Registry description

    Severe BPD is defined based on the classification according to Jensen et al., 2019

  3. 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

    Time frame · Baseline through 40 weeks postmenstrual age (PMA)

    Registry description

    Severe IVH as classified according to the Volpe criteria

  4. 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)

  5. 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

  6. 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

  7. Chronic respiratory morbidity outcomes at 24 months CA

    Time frame · 24 months CA

  8. Incidence and severity of BPD

    Time frame · Baseline through 36 weeks postmenstrual age (PMA)

    Registry description

    BPD severity is defined by the modified NICHD severity grading

  9. 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)

  10. Incidence and severity of IVH

    Time frame · Baseline through 36 weeks postmenstrual age (PMA)

    Registry description

    Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria

  11. Neurodevelopment outcomes

    Time frame · From 6 months CA through 24 months CA

    Registry description

    Neurodevelopmental impairment, Physical and cognitive development will be measured by ASQ®-3 administered at 12 and 24 months CA.

  12. Incidence of Retinopathy of Prematurity (ROP)

    Time frame · Baseline through 40 weeks PMA

    Registry description

    ROP is classified according to the International Classification

  13. Mortality from randomization through to 24 months CA

    Time frame · From birth through 24 months CA

    Registry description

    Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA.

  14. Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)

    Time frame · Baseline through 36 weeks PMA

    Registry description

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of BPD

  15. Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)

    Time frame · Baseline through 40 weeks PMA

    Registry description

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of IVH

  16. Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC)

    Time frame · Baseline through 40 weeks PMA

    Registry description

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of NEC

  17. Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)

    Time frame · Baseline through 40 weeks PMA

    Registry description

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of ROP

  18. To assess the safety profile of OHB-607 as compared to the SNC group.

    Time frame · Baseline through 24 months CA

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

10 results

rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial.

Ley et al. 2019The Journal of pediatricscited by 124

PMID 30471715PMC6389415DOI 10.1016/j.jpeds.2018.10.033PUB-30471715

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

More studies

1 study on this page

Indexing hint: Clinical trial · 2026

Randomised Phase 2b trial of rhIGF-1/rhIGFBP-3 (OHB-607) for bronchopulmonary dysplasia prevention in preterm neonates: study protocol

Baraldi et al. 2026BMJ paediatrics opencited by 7

PMID 41786363PMC12970049DOI 10.1136/bmjpo-2025-004196PUB-41786363

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHellstrom W, Hortensius LM, Lofqvist C, Hellgren G, Tataranno ML, Ley D, Benders MJNL, Hellstrom A, Bjorkman-Burtscher IM, Heckemann RA, Savman K. Postnatal serum IGF-1 levels associate with brain volumes at term in extremely preterm infants. Pediatr Res. 2023 Feb;93(3):666-674. doi: 10.1038/s41390-022-02134-4. Epub 2022 Jun 9. PMID 35681088

Eligibility

Who could join, as posted.

Sex
All
Age
from 0 Hours up to 24 Hours
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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