Deferred registration: Fortrea code 780279
This study is an early-phase clinical trial (Phase 1) designed for infants up to one year old. The trial is coordinated by Fortrea, a medical research organisation operating in the UK. At present, the full details—such as the specific condition being treated, the medicine being tested, and the exact entry rules—are not publicly listed. This is because the UK Health Research Authority (HRA) has granted a formal 'deferral'. A deferral allows research teams to delay releasing sensitive study details for a limited time, often to protect scientific patents or early research data. Even though public details are paused, the trial must still follow strict UK safety and ethics rules. The full trial details, including how to take part, will be added to the public record as soon as the deferral period expires.
At a glance
What is this study about?
This clinical trial, identified by the code Fortrea 780279, is a Phase 1 study focused on infants between 0 and 12 months of age. Phase 1 trials are the earliest phase of testing in people. Their main goal is to test safety, understand how a treatment acts inside the body, and check for any side effects before moving to larger groups.
Normally, clinical trial registries share full scientific details right away. In this case, the Health Research Authority (HRA)—the UK body that protects the rights and safety of research participants—has approved a 'deferred registration'. This means the researchers have permission to keep specific scientific details confidential for a limited time. This often happens in commercially sensitive work to protect scientific inventions while early research gets under way.
It is reassuring to know that a deferral does not mean safety standards are skipped. Any trial in the UK, especially one involving babies, must undergo rigorous independent ethical review. The study team must prove to independent panels that the welfare of the children is properly protected before any testing can start.
Once the official deferral date arrives, the study team must update this public listing with full information. This will include the medical condition, the medicine or intervention being used, the trial sites, and the exact eligibility requirements.
Key takeaways
- The trial is a Phase 1 study focused on babies aged 0 to 1 year.
- Full details about the condition and treatment are currently delayed under an approved UK deferral.
- The delay has been formally authorised by the UK Health Research Authority.
- All standard UK ethical reviews and patient safety safeguards still apply.
- Full trial information will be added to the registry once the deferral period ends.
Who may be eligible?
Currently, the only confirmed eligibility detail is that the study involves infants aged from birth up to 1 year old (0 to 12 months). The trial is open to both boys and girls.
Specific medical rules—such as whether the trial is for healthy babies or infants with a particular medical condition—have been deferred by the Health Research Authority. As a result, exact inclusion and exclusion criteria are not yet visible to the public.
Parents looking for trials for their baby will need to wait until the deferral expires, or talk to their baby's hospital specialist to see if their local paediatric unit is taking part in any approved infant studies.
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.
- The child is an infant between 0 and 1 year old
- You are a parent or legal guardian able to make medical decisions for the infant
- You are based in the UK and able to visit a participating research hospital
- You are comfortable with early-phase (Phase 1) research that involves close monitoring
- You are willing to wait for full medical details to be published or discussed with your doctor
What does participation involve?
Because the full study details are currently deferred, specific visit schedules and treatments have not been published yet. In general, Phase 1 studies in infants involve careful health checks, close monitoring by specialist doctors and nurses, and regular clinic visits. Taking part may involve giving a treatment (such as a liquid medicine, injection, or drip) and taking routine samples like blood or urine tests. The exact number of visits, tests, and total length of the study will be revealed once the deferral period ends.
Potential risks and benefits
Locations (1)
- Fortrea Clinical Research Unit (Drapers Yard)City onlyLeeds, England
Common questions
Why are the study details kept private?
The UK Health Research Authority has approved a deferral. This temporarily delays the release of scientific details, usually to protect intellectual property or patent applications.
Does a deferral mean the trial is less safe?
No. The trial must still meet all strict UK legal, safety, and ethical standards before any babies can take part.
What is a Phase 1 clinical trial?
Phase 1 is the first stage of testing a treatment in people, focusing mainly on safety, dosage, and watching for side effects.
Who is Fortrea?
Fortrea is a global clinical research organisation that helps design, set up, and run clinical trials for medical treatments.
When will we know more about this trial?
Full details will be added to the official public trial registry on or before the agreed deferral expiry date.
How to find out more
Benjamin Monaghan
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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