RecruitingPHASE2INTERVENTIONAL

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

This important study is investigating a new medication called OHB-607. Its main goal is to find out if this medicine can stop or reduce the severity of a lung condition called Bronchopulmonary Dysplasia (BPD) in babies who are born extremely prematurely. BPD can cause long-term breathing difficulties for these tiny infants. Researchers want to compare the health outcomes of extremely premature babies who receive OHB-607 with those who receive the usual excellent care without the study medicine. They are specifically looking at how well the new medicine works and if it has any side effects, aiming to improve the health and future lives of these vulnerable babies. The study is in an early phase of testing to understand its potential benefits and safety.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

OHB Neonatology Ltd.

Enrolment target

338

Start

09 May 2019

Estimated completion

21 Jan 2028

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

What is this study about?

When babies are born much earlier than expected, especially before 28 weeks of pregnancy, their lungs are often not fully developed. This can lead to a serious lung condition called Bronchopulmonary Dysplasia, or BPD. BPD can cause breathing difficulties that might last for a long time, sometimes even needing ongoing support like oxygen. This study is exciting because it's looking into a new medicine, OHB-607, that researchers hope could help prevent BPD from happening in these very tiny, premature babies.

The main idea is to see if giving OHB-607 to extremely premature babies shortly after birth can make a difference. The study will carefully compare these babies with similar babies who receive the very best standard care but don't get the study medicine. By doing this, the researchers can understand if OHB-607 is effective in reducing the impact of lung problems and if it is safe to use.

This research is really important because if OHB-607 works, it could significantly improve the health and quality of life for many premature babies. It's about giving them the best possible start and reducing the risks of long-term breathing difficulties. The study will also be looking at other common issues for premature babies, like bleeding in the brain (Intraventricular Hemorrhage) and an eye condition called Retinopathy of Prematurity, to see if the medicine has any impact on these conditions too.

Key takeaways

This study investigates a new medicine (OHB-607) for extremely premature babies.
The main goal is to prevent a serious lung condition called Bronchopulmonary Dysplasia (BPD).
It compares the new medicine with standard care.
The study also looks at other common issues affecting premature babies, such as brain bleeds and eye problems.
Participation requires parental consent and is for babies born between 23 and 27 weeks of pregnancy.
The aim is to improve the long-term health of vulnerable premature infants.

Who may be eligible?

For a baby to be considered for this study, their parents or guardians must first agree and sign consent forms. This is really important as it ensures everyone understands what the study involves before anything else happens.

Only babies born between 23 weeks and 0 days, up to 27 weeks and 6 days of pregnancy, can take part. This specific timeframe is chosen because babies born within this window are at the highest risk of developing BPD and are therefore the target group for this new medicine.

Babies would not be able to join if they have certain serious health problems already identified, such as major birth defects, known genetic conditions, or significant brain issues that would affect the study results or put them at higher risk. Also, if a baby's parents cannot commit to following the study's plan, participation might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Has your baby's parent(s) signed all consent forms?
Was your baby born between 23 weeks and 0 days and 27 weeks and 6 days of pregnancy?
Does your baby have any major birth defects or known genetic conditions?
Is your baby currently taking part in another study with a new medical treatment?
Can you commit to attending all study appointments and following the study plan?

Answer every question to see your result.

What does participation involve?

If a baby is eligible and their parents agree to take part, the baby would receive the study medicine, OHB-607, or standard care. This is a "Phase 2" study, meaning researchers are still learning about the best ways to use the medicine and its effects. We expect that there will be regular checks and scans for the baby while they are in hospital, similar to the care they would already be receiving, but with some extra measurements related to the study. The doctors and nurses will closely monitor the baby's health throughout their hospital stay. The total duration of the study for each baby would involve their initial hospitalisation and any follow-up appointments necessary to track their development regarding lung health, brain, and eyes. All specific details about visits, tests, and medication will be fully explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For babies in this study, the potential benefit is that OHB-607 might help prevent or lessen the severity of serious lung problems, improving their long-term health. However, as with any new medicine, there could be unknown side effects or the medicine might not work as hoped. The study team will monitor babies very closely for any changes or problems. Parents always have the right to withdraw their baby from the study at any time, for any reason, without it affecting their baby's medical care.

Locations (66)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arkansas Children's Hospital
Verified postcode
Little Rock, United States· Recruiting
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States· Recruiting
Children's Hospital of Orange County
Verified postcode
California City, United States· Recruiting
LAC USC Medical Center
Verified postcode
Los Angeles, United States· Active not recruiting
Jackson Memorial Hospital
Verified postcode
Miami, United States· Recruiting
Tampa General Hospital
Verified postcode
Tampa, United States· Recruiting
University of Illinois at Chicago
Verified postcode
Chicago, United States· Recruiting
Riley Hospital for Children
Verified postcode
Indianapolis, United States· Recruiting
Memorial Hospital of South Bend
Verified postcode
South Bend, United States· Recruiting
Norton Children's Hospital
Verified postcode
Louisville, United States· Recruiting
Ochsner Baptist Medical Center
Verified postcode
New Orleans, United States· Recruiting
Tufts Medical Center
Verified postcode
Boston, United States· Recruiting

Common questions

What is Bronchopulmonary Dysplasia (BPD)?

BPD is a chronic lung condition that can affect babies born very prematurely, causing breathing difficulties because their tiny lungs are not fully developed.

What is OHB-607?

OHB-607 is a new experimental medicine being tested in this study to see if it can help prevent BPD in extremely premature babies.

Will my baby definitely get the study medicine?

Not necessarily. In studies like this, some babies receive the new medicine and others receive standard care. This helps researchers compare the effects fairly.

How long will my baby be involved in the study?

Your baby's involvement would include their hospital stay and any follow-up appointments needed to check their health as part of the study. The study team will provide exact details.

Can I take my baby out of the study if I change my mind?

Yes, absolutely. You can withdraw your baby from the study at any time, and this will not affect their medical care in any way.

How to find out more

OHB Contact

CMO@Oakhillbio.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.