CompletedPhase 1

Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease

United Kingdom18 participantsStarted 2024-04-06

Plain-language summary

The purpose of this study is to identify the safest dose of recombinant surfactant protein D (drug name: rfhSP-D) that can be administered to preterm infants born at less than 30 weeks gestation, and to help identify whether this can prevent the development of neonatal chronic lung disease.

Who can participate

Age range

23 Weeks – 30 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Inborn infants born at between 23 weeks and 0 days and 29 weeks and 6 days gestation.
. 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.
. Receiving standard surfactant therapy
. Clinically stable on mechanical ventilation. Stability is defined at the time of IMP instillation and is defined below.
. Written informed consent from parents/guardians/person with legal responsibility
. Blood gases within the normal range for preterm infants (pH\>7.20; paCO2 \<60mmHg)
. Mean blood pressure with or without inotropic support at at least gestational age or above (mmHg)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurence of Dose Limiting Events to assess the safety profile of the IMP (rfhSP-D)

Timeframe: Day 0 to 96 hours

To find recommended Phase 2 Dose of rfhSP-D

Timeframe: Day 0 to the point of hospital discharge (40 weeks post-menstrual age)

Trial details

NCT IDNCT05898633

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-05

View on ClinicalTrials.gov More Chronic Lung Disease of Prematurity trials

Who can participate

Age range

23 Weeks – 30 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Inborn infants born at between 23 weeks and 0 days and 29 weeks and 6 days gestation.
. 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.
. Receiving standard surfactant therapy
. Clinically stable on mechanical ventilation. Stability is defined at the time of IMP instillation and is defined below.
. Written informed consent from parents/guardians/person with legal responsibility
. Blood gases within the normal range for preterm infants (pH\>7.20; paCO2 \<60mmHg)
. Mean blood pressure with or without inotropic support at at least gestational age or above (mmHg)

Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria