Not recruiting

Study on Mecasermin Rinfabate for Preventing Chronic Lung Disease in Extremely Premature Babies

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Chronic Lung Disease, which often affects extremely premature babies. The study is evaluating a new treatment called Mecasermin rinfabate, also known by its code name OHB-607. This treatment is a solution given through an infusion, which means it is delivered directly into the bloodstream. The purpose of the study is to see if this new treatment can help prevent a specific type of lung disease in premature babies, known as Bronchopulmonary Dysplasia, which is a common cause of long-term lung problems in these infants.

The study will compare the effects of OHB-607 with the standard care that is usually given to premature babies. Participants in the study will be randomly assigned to receive either the new treatment or the standard care. The study will monitor the babies' health and development over a period of time to see if the new treatment is safe and effective. The researchers will look at how many babies develop severe lung disease or other complications, and they will also track the overall health and growth of the babies involved in the study.

Throughout the study, the health of the babies will be closely monitored by healthcare professionals. The study aims to provide valuable information on whether OHB-607 can reduce the risk of severe lung disease in extremely premature infants, potentially leading to better outcomes for these vulnerable patients. The study will continue to gather data until the babies reach a certain age, ensuring a comprehensive understanding of the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the parent(s) of the participant must provide written informed consent. This consent is necessary before any study-related procedures can begin. The consent form must be approved by an ethics committee.
The participant must be between 23 weeks and 27 weeks and 6 days of gestational age to be eligible for the study.
Step 2
Randomization
Participants are randomly assigned to one of two groups. One group will receive the experimental drug OHB-607, and the other group will receive standard neonatal care.
This process ensures that each participant has an equal chance of being placed in either group.
Step 3
Treatment administration
Participants in the experimental group will receive OHB-607 as a solution for infusion. This means the medication is given through a vein using an intravenous (IV) line.
The frequency and duration of the treatment will be determined by the study protocol and medical team.
Step 4
Monitoring and follow-up
Participants will be closely monitored throughout the study to assess the safety and effectiveness of the treatment.
Regular follow-up visits and telephone calls will be scheduled to collect information on the participant's health and development.
Step 5
End of study participation
The study will continue until the participant reaches 36 weeks postmenstrual age or until the study's end date, whichever comes first.
At the end of the study, the participant's health and development will be evaluated to determine the outcomes of the treatment.

Who can join the trial?

3 criteria

Written informed consent must be signed and dated by the subject's parent(s) before any study-related procedures. This means the parents agree to let their child participate in the study after understanding what it involves.
Written informed consent must also be signed and dated by the subject's birth mother before providing any study-related information about her medical history, pregnancy, and the birth of the subject. This ensures the birth mother agrees to share this information.
Subjects must be between 23 weeks +0 days and 27 weeks +6 days gestational age (GA). Gestational age is the age of the baby calculated from the first day of the mother's last menstrual period.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a severe allergic reaction to any of the ingredients in the study medication.
Patients who are unable to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have been diagnosed with a mental health disorder that is not well controlled.
Patients who have a known infection that requires treatment with antibiotics.
Patients who have had a major surgery within the last 3 months.
Patients who have a history of heart disease or stroke.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

OHB-607 is a medication being tested to see if it can help prevent a lung condition called bronchopulmonary dysplasia (BPD) in premature babies. BPD is a common cause of chronic lung disease in babies born too early. This medication is being compared to the usual care that newborns receive to see if it can reduce the number of severe BPD cases or prevent death in these babies by the time they reach 36 weeks of age. The goal is to find out if OHB-607 can make a significant difference in the health of these infants compared to the standard care they would normally receive.

Mecasermin Rinfabate

What is already known about the treatment

OHB-607 – OHB-607 is administered as part of a clinical trial to prevent bronchopulmonary dysplasia, a common cause of chronic lung disease in premature infants. Currently, it is being studied in a Phase 2b trial to evaluate its effectiveness and safety compared to standard neonatal care. The main therapeutic indication for OHB-607 is to reduce the incidence of severe bronchopulmonary dysplasia or death in premature infants by 36 weeks postmenstrual age. The exact molecular mechanism of action is not detailed in the available data, but it is being investigated for its potential benefits in neonatal care. OHB-607 falls under the pharmacological classification of investigational drugs, as it is still undergoing clinical evaluation.

Investigated diseases

Chronic Lung Disease – Chronic Lung Disease, often seen in premature infants, involves long-term respiratory problems due to underdeveloped lungs. It typically begins with the need for prolonged oxygen therapy or mechanical ventilation shortly after birth. Over time, the condition can lead to inflammation and scarring in the lungs, affecting their ability to function properly. As the child grows, symptoms may include difficulty breathing, wheezing, and frequent respiratory infections. The severity of the disease can vary, with some children experiencing mild symptoms and others requiring ongoing respiratory support. The condition may improve as the child ages, but some may continue to have respiratory issues into adulthood.