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New drug could shield preemie lungs from chronic disease

NCT ID NCT05898633

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tested a new drug called rfhSP-D in 18 premature babies born before 30 weeks. The goal was to find the safest dose that might prevent chronic lung disease, a common complication in preemies. The drug was given along with standard care to babies on breathing machines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
recombinant surfactant protein D (rfhSP-D)
What this could lead to
If successful, this could lead to a new treatment to prevent chronic lung disease in premature infants, reducing lifelong breathing problems.
What could go wrong
This is a very early Phase 1 trial with only 18 babies, focused on safety. The drug may not work or could have side effects. Much more research is needed.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

23 to 30 weeks

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.

Participant Inclusion Criteria: 1. Inborn infants born at between 23 weeks and 0 days and 29 weeks and 6 days gestation. 2. Infant must be intubated or planned to be intubated for respiratory distress at time of eligibility check, and this should be done within 12 hours from time of birth. 3. Receiving standard surfactant therapy 4. Clinically stable on mechanical ventilation. Stability is defined at the time of IMP instillation and is defined below. 5. Written informed consent from parents/guardians/person with legal responsibility Definition of stability: 1. Blood gases within the normal range for preterm infants (pH\>7.20; paCO2 \<60mmHg) 2. Mean blood pressure with or without inotropic support at at least gestational age or above (mmHg) 3. No evidence of a pneumothorax 4. Clinical observations within acceptable range for an infant of that gestational age 5. No stability concerns from the attending neonatologist Participant Exclusion Criteria: 1. Congenital anomalies i.e any major antenatal diagnosed congenital abnormalities such as congenital heart disease, suspected or known chromosomal abnormalities 2. Parents/legal guardians unable to give consent due to learning or other difficulties 3. Infants requiring only CPAP support without the need for surfactant replacement therapy, i.e. without endotracheal intubation 4. Infants born in very poor condition and judged too sick or unstable to be included (high risk of mortality) in an experimental first in human study, for example infants that are requiring maximal intensive care therapy and have findings such as a grade IV intraventricular haemorrhage that is likely to be life limiting. 5. Infants that are born out of the participating site. 6. Participation in any other interventional study (participation in an observational study is permissible).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University College London Hospitals

    London, United Kingdom

More trials for these conditions

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