Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease (RESPONSE)
Chronic Lung Disease of Prematurity, Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
About this trial
This is an interventional treatment trial for Chronic Lung Disease of Prematurity focused on measuring Preterm Infants, Recombinant Surfactant Protein D
Eligibility Criteria
Participant Inclusion Criteria: Inborn infants born at between 23 weeks and 0 days and <28 weeks and 0 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 Definition of stability: 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 Clinical observations within acceptable range for an infant of that gestational age No stability concerns from the attending neonatologist Participant 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. Infants that are born out of the participating site. Participation in any other interventional study (participation in an observational study is permissible).
Sites / Locations
Arms of the Study
Arm 1
Experimental
Recombinant fragment of human surfactant protein D (rfhSP-D) administration
This 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.