Using a new surfactant to prevent lung disease in premature infants

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

This study is testing a new treatment to see if a special lung medicine can help prevent lung disease in premature infants born before 30 weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 23 Weeks to 30 Weeks
• Sex: All
• Sponsor: University College, London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT05898633 on ClinicalTrials.gov

What this trial studies

This Phase I interventional study aims to determine the safest dose of recombinant surfactant protein D (rfhSP-D) for preterm infants born before 30 weeks gestation. The study will involve administering rfhSP-D via an endotracheal tube to assess its safety and effectiveness in preventing neonatal chronic lung disease. Up to 24 infants will be enrolled, with dose escalation based on the occurrence of dose limiting events. The study will also measure the concentration of the drug in lung secretions and serum to evaluate its impact.

Who should consider this trial

Good fit: Ideal candidates are inborn infants born between 23 weeks and 0 days and 29 weeks and 6 days gestation who are intubated for respiratory distress.

Not a fit: Patients with congenital anomalies or those not requiring intubation for respiratory distress may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of chronic lung disease in preterm infants.

How similar studies have performed: Previous studies have shown promise in using surfactant proteins for lung disease treatment, but this specific approach with rfhSP-D is novel.

Eligibility criteria

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).

Where this trial is running

London

• University College London Hospitals — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Howard Clark, MBBS — University College London Hospital
• Study coordinator: Trial Manager

Conditions Chronic Lung Disease of Prematurity; Respiratory Distress Syndrome in Premature Infant; Bronchopulmonary Dysplasia; Preterm Infants; Recombinant Surfactant Protein D