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Chronic Lung Disease of PrematurityPhase 1RESPONSENCT05898633

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

A Phase 1 study testing Recombinant fragment of human surfactant protein D (rfhSP-D) in people with Chronic Lung Disease of Prematurity and Respiratory Distress Syndrome in Premature Infant, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 23 to 30 weeks
What is being tested?
Recombinant fragment of human surfactant protein D (rfhSP-D)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
6 Apr 2024to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 30 weeks
  • All sexes
  • No healthy volunteers
  • Child

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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London Hospitals

    London

Other trials in United Kingdom

About this study

Official title: Phase 1 Safety Trial of Recombinant Surfactant Protein D to Prevent Neonatal Chronic Lung Disease

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.

Read the detailed description

This is a Phase I, dose escalation safety study that aims to identify the recommended phase 2 dose of recombinant fragment of human surfactant protein D (rfhSP-D) (drug name: rfhSP-D) for infants at risk of neonatal chronic lung disease. This study will aim to establish if the administration of rfhSP-D to the lungs of preterm babies, via an endotracheal tube, is safe at the proposed dosage range (1mg/kg - 4mg/kg) and whether this dose results in detectable concentrations in lung secretions or serum.

Surfactant protein D (SP-D) is a naturally occurring component of the surfactant system with anti-inflammatory properties. Current surfactant replacement therapy contains phospholipids and surfactant proteins B and C (SP-B and SP-C) but no surfactant protein A (SP-A) or surfactant protein D (SP-D).

Proof of concept regarding the anti-infective and anti-inflammatory activity of SP-D has been achieved in mouse and a preterm lamb models of lung disease and supports increasing evidence of the role played by deficiency of SP-D in human respiratory diseases.

Subjects will be enrolled in cohorts with increasing dose. Whether or not the dose is escalated will depend on the occurrence of dose limiting events (DLE) in all current patients and the doses that they have received. A model will be used to estimate the risk of DLE per dose level. Initial estimates of these risks will be updated using data collected throughout the trial.

Up to 24 infants of less than 30 weeks gestation will be recruited in the study and receive intra-tracheal administration of SP-D59, in the dose range 1mg/kg, 2mg/kg or 4mg/kg per dose for up to 3 doses. The first dose of SP-D59 will be given as soon as possible after the first dose of standard surfactant therapy (e.g., Curosurf). Subsequent doses of the IMP will be given at 12 hours and 24 hours after the first dose was administered.

Being tested
Recombinant fragment of human surfactant protein D (rfhSP-D)
Keywords
Preterm Infants, Recombinant Surfactant Protein D
Medical subject headings
Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant fragment of human surfactant protein D (rfhSP-D)Drug

    Also called rfhSP-D

    Administration of rfhSP-D

Study groups in NCT05898633
Study groupRoleWhat they receive
Recombinant fragment of human surfactant protein D (rfhSP-D) administrationExperimentalThis is a single arm trial with administration of rfhSP-D. All participants will be administered rfhSP-D via an endotracheal tube in 1-3 doses in the first 24-48hrs after birth whilst the infant is still intubated and ventilated. A dose escalation design from 1mg/kg to 4mg/kg will be used. Infants are enrolled in cohorts of three, with the first cohort receiving the lowest dose 1mg/kg. Participants are followed up until they are discharged from hospital.
Receives: Drug: Recombinant fragment of human surfactant protein D (rfhSP-D)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    To assess the safety profile of rfhSP-D across dose levels based on the occurrence of Dose Limiting Events (DLEs) which are events Garde 3 or above on the NAESS scale related to the IMP

    Measured: Day 0 to 96 hours

  2. To find recommended Phase 2 Dose of rfhSP-D

    To establish the Recommended Phase 2 Dose (RP2D) of rfhSP-D for preterm infants born at gestational age of 23 weeks to 29 weeks + 6 days.

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

Secondary outcomes (3)

  1. Occurrence of non-dose limiting events, including SAE/AEs

    To establish the safety profile of rfhSP-D across dose levels based on the occurrence of non-DLEs, including SAE/AEs.

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

  2. Systemic absorption of rfhSP-D

    To evaluate systemic absorption of rfhSP-D using serial measurements of rfhSP-D in serum and its continued presence in tracheal fluid.

    Measured: Day 0 to 36 weeks post menstrual age

  3. Effects of rfhSP-D on the cell counts of inflammatory markers

    To determine the effect of rfhSP-D on Inflammatory markers in the lung secretions (eg.cell counts of the following markers: neutrophils, macrophages, MMPs, neutrophil elastase, IL-8,IL-6, IL-1).

    Measured: Day 0 to 36 weeks post menstrual age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start6 Apr 2024
  3. Primary completion5 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A Bayesian Continual Reassessment Method (CRM) will be used for the RESPONSE trial to inform how the IMP dose should be adapted for the next cohort based on past trial data. The CRM is a model-based design that uses a statistical model to estimate the risk of dose limiting events (DLE) per dose level. The target level of DLEs is set at 20% The CRM model does not allow dose-skipping. The recommended phase 2 dose in terms of safety (efficacy will also be taken into account) will be the highest dose level that has an estimated probability of DLE closest but below the target DLE level of 20%.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898633
Sponsor's protocol ID
18/0564
Other IDs
2021-001824-16
Acronym
RESPONSE
Status last verified
Apr 2026
First submitted
24 Mar 2023
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to make individual participant data available to other researchers. Written requests will be considered by the RESPONSE Trial Management Group.

Publications

  • Bhatt R, Madsen J, Castillo-Hernandez T, Chant K, Dehbi HM, Marlow N, Clark H. Recombinant fragment of human surfactant protein D to prevent neonatal chronic lung disease (RESPONSE): a protocol for a phase I safety trial in a tertiary neonatal unit. BMJ Open. 2024 Aug 17;14(8):e086394. doi: 10.1136/bmjopen-2024-086394.

    PubMed 39153779

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant fragment of human surfactant protein D (rfhSP-D) in people with Chronic Lung Disease of Prematurity and Respiratory Distress Syndrome in Premature Infant, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of Dose Limiting Events to assess the safety profile of the IMP (rfhSP-D) (time frame: Day 0 to 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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