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Breakthrough trial aims to prevent lung damage in tiniest newborns

NCT ID NCT03253263

Prevention Sponsor: OHB Neonatology Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests an investigational drug called OHB-607 to see if it can prevent bronchopulmonary dysplasia (BPD), a serious chronic lung disease, in extremely premature infants. About 338 babies will be randomly assigned to receive either the drug or standard care. The goal is to reduce severe lung problems and help babies breathe on their own sooner.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

295 people

The number who actually took part.

Started

May 2019

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 24 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchopulmonary dysplasia Chronic lung disease of prematurity Intraventricular hemorrhage Retinopathy of prematurity (ROP)

Contacts and locations

Locations

  • Academisch Medisch Centrum Amsterdam

    Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3500, United States

  • Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

    Chertsey, Surrey, KT16 0PZ, United Kingdom

  • Azienda Ospedaliera Di Padova

    Padova, Veneto, 35128, Italy

  • Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

    Florence, 50134, Italy

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centro Hospitalar Lisboa

    Lisbon, 1649-035, Portugal

  • Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

    Porto, 4050-651, Portugal

  • Chelsea and Westminster NHS Trust

    London, SW3 6JJ, United Kingdom

  • Children's Hospital of Orange County

    California City, California, 92868, United States

  • Children's Minnesota - Children's Hospital and Clinics

    Saint Paul, Minnesota, 55102, United States

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

    Saint Paul, Minnesota, 55102, United States

  • Cork University Maternity Hospital

    Cork, Wilton, T12YE02, Ireland

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Hospital Garcia de Orta

    Almada, 2801-951, Portugal

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

    Genova, 16147, Italy

  • Jackson Memorial Hospital

    Miami, Florida, 33136-1005, United States

  • Klinikum Nürnberg

    Nuremberg, 90479, Germany

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken, 710-0052, Japan

  • Liverpool Women's Hospital - PPDS

    Liverpool, L69 3BX, United Kingdom

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX, Netherlands

  • Maria Fareri Children's Hospital

    Valhalla, New York, 10595, United States

  • Mater Misericordiae Limited

    South Brisbane, Qld 4101, Australia

  • Maternidade Alfredo da Costa

    Lisbon, 1069-089, Portugal

  • Medical University of South Carolina Children Hospital

    Charleston, South Carolina, 29425-8908, United States

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601-1078, United States

  • Nagano Children's Hospital

    Azumino, Nagano, 399-8205, Japan

  • National Center for Child Health and Development

    Tokyo, 157-8535, Japan

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115, United States

  • Oklahoma Children's Hospital - PIN

    Oklahoma City, Oklahoma, 73104, United States

  • Osaka Women's and Children's Hospital

    Izumi, Ôsaka, 594-1101, Japan

  • Oulun Yliopistollinen Sairaala

    Oulu, 90220, Finland

  • Presidio Ospedaliero Di Treviso Ca' Foncello

    Treviso, 31100, Italy

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Royal Hospital for Women

    Randwick, New South Wales, 2031, Australia

  • Royal Women's Hospital

    Parkville, 3052, Australia

  • Sainte Justine Hospital

    Montreal, Quebec, Canada

  • Saitama Medical Center

    Kawagoe-shi, Saitama, 350-8550, Japan

  • Saitama Prefectural Children's Medical Center

    Saitama, Saitama, 330-8777, Japan

  • Showa Medical University Hospital

    Tokyo, 142-8666, Japan

  • Skanes Universitetssjukhus

    Lund, SE-22185, Sweden

  • St. Mary's Hospital

    Manchester, M13 9WL, United Kingdom

  • Tampa General Hospital

    Tampa, Florida, 33606-3571, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Tokyo Metropolitan Children's Medical Center

    Tokyo, 183-8561, Japan

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1553, United States

  • US Davis

    Sacramento, California, 95817, United States

  • UT Health Science Center

    San Antonio, Texas, 78229, United States

  • UVA Children's Hospital

    Charlottesville, Virginia, 22903, United States

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • University Hospital Coventry

    Coventry, CV2 2DX, United Kingdom

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72202-3500, United States

  • University of Cambridge

    Cambridge, CB2 0QQ, United Kingdom

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Louisville Hospital

    Louisville, Kentucky, 40202, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4500, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • Virginia Commonwealth University - Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23298-5075, United States

  • Westmead Hospital

    Westmead, New South Wales, NSW 2145, Australia

  • Wilhelmina Children Hospital-University Medical Center Utrecht

    Utrecht, 3584 EA, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.