Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT03253263 · View on ClinicalTrials.gov ↗

Study Summary

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

  • DRUG OHB-607

Study Locations (20)

Arkansas

  • Arkansas Children's Hospital — Little Rock
  • University of Arkansas for Medical Sciences — Little Rock

California

  • Children's Hospital of Orange County — California City
  • LAC USC Medical Center — Los Angeles

Florida

  • Jackson Memorial Hospital — Miami
  • Tampa General Hospital — Tampa

Indiana

  • Riley Hospital for Children — Indianapolis
  • Memorial Hospital of South Bend — South Bend

Massachusetts

  • Tufts Medical Center — Boston
  • Boston Children's Hospital — Boston

Minnesota

  • Children's Minnesota - Children's Hospital and Clinics - St. Paul — Saint Paul
  • Children's Minnesota - Children's Hospital and Clinics — Saint Paul

New York

  • University of Rochester — Rochester
  • Maria Fareri Children's Hospital — Valhalla

Illinois

  • University of Illinois at Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2019-05-09
Est. Completion 2028-01-21
Phase Phase 2

Sponsor

OHB Neonatology

28 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03253263

The ClinicalTrials.gov registry entry for NCT03253263 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHB Neonatology, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 1 intervention — of which OHB-607 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03253263 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Arkansas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03253263 about?

NCT03253263 is a clinical study titled "A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants". 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.

What is the current status of trial NCT03253263?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2019-05-09. Estimated completion is 2028-01-21.

What conditions does trial NCT03253263 study?

This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP), Chronic Lung Disease of Prematurity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03253263?

The interventions under investigation include: OHB-607 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03253263?

This trial is sponsored by OHB Neonatology, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03253263 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial