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Preventing lung disease in extremely premature infants with OHB-607

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

PHASE2 · Oak Hill Bio Ltd · NCT03253263

This study tests if a new drug called OHB-607 can help extremely premature babies avoid lung disease compared to just standard care.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment338 (estimated)
Ages0 Hours to 24 Hours
SexAll
SponsorOak Hill Bio Ltd (industry)
Locations66 sites (Little Rock, Arkansas and 65 other locations)
Trial IDNCT03253263 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of an investigational drug, OHB-607, in preventing Bronchopulmonary Dysplasia (BPD) in extremely premature infants. The trial compares outcomes in infants receiving OHB-607 to those receiving standard neonatal care alone. The goal is to reduce the incidence of chronic lung disease associated with prematurity. Participants must be between 23 and 27 weeks gestational age.

Who should consider this trial

Good fit: Ideal candidates are extremely premature infants born between 23 weeks and 27 weeks gestational age.

Not a fit: Patients with major congenital malformations or known chromosomal abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of chronic lung disease in extremely premature infants.

How similar studies have performed: Other studies have explored treatments for Bronchopulmonary Dysplasia, but the specific approach with OHB-607 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Little Rock, Arkansas and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.