Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease (NCT05898633) | Clinical Trial Compass
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 range23 Weeks – 30 Weeks
SexALL
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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)
✓. No evidence of a pneumothorax
Exclusion criteria
✕. Congenital anomalies i.e any major antenatal diagnosed congenital abnormalities such as congenital heart disease, suspected or known chromosomal abnormalities
✕. Parents/legal guardians unable to give consent due to learning or other difficulties
✕. Infants requiring only CPAP support without the need for surfactant replacement therapy, i.e. without endotracheal intubation
✕. 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.
What they're measuring
1
Occurence of Dose Limiting Events to assess the safety profile of the IMP (rfhSP-D)
Timeframe: Day 0 to 96 hours
2
To find recommended Phase 2 Dose of rfhSP-D
Timeframe: Day 0 to the point of hospital discharge (40 weeks post-menstrual age)