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

Launched by UNIVERSITY COLLEGE, LONDON · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called recombinant surfactant protein D (rfhSP-D) to see if it can help prevent chronic lung disease in premature infants. The focus is on babies born before 30 weeks of pregnancy, who often face breathing difficulties due to their underdeveloped lungs. The trial aims to find the safest dose of this treatment for these infants and to understand if it can improve their lung health.

To be eligible for this study, infants should be born between 23 weeks and 29 weeks and 6 days of pregnancy and be in need of breathing assistance right after birth. They must also be receiving standard treatment for lung issues and be stable enough for the trial. Parents will need to provide consent for their baby to participate. If involved, families can expect close monitoring of their baby's health throughout the study. It's important to know that this trial is still recruiting participants, and only certain infants can take part based on specific health criteria.

Gender

ALL

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).