RESPONSE
Research type
Research Study
Full title
RESPONSE - Phase 1 safety trial of recombinant surfactant protein D to prevent neonatal chronic lung disease
IRAS ID
1004422
Contact name
Alyson MacNeil
Contact email
Sponsor organisation
The Comprehensive Clinical Trials Unit at University College London
Eudract number
2021-001824-16
ISRCTN Number
ISRCTN17083028
Research summary
Bronchopulmonary Dysplasia (BPD), also known as Chronic Lung Disease (CLD), is a serious long term lung condition that can affect up to 70% of infants born prematurely before 28 weeks of pregnancy. This is because their lungs have not fully developed, and they do not produce a soapy substance called surfactant. It is not clear why they develop CLD, but inflammation and infection have a role. Current surfactant replacement therapy consists of phospholipids and surfactant proteins B and C, but no surfactant protein A or surfactant protein D (SP-D). SP-D has anti-inflammatory and anti-infection properties, both of which play a role in the development of CLD.
The RESPONSE trial is a first in human trial of recombinant SP-D (rfhSP-D), which is a manufactured version of SP-D that is a part of the naturally occurring protein.
The aim of the trial is to find out the safest dose of rfhSP-D for premature infants (under 28 weeks gestation) who are at high risk of CLD, and how it helps to prevent CLD.Up to 24 participants will be recruited to the trial. Each infant will receive up to three administrations of rfhSP-D, either 1mg/kg, 2mg/kg or 4mg/kg. The infants will be enrolled in groups with dose level increase in each group after it has been deemed safe to increase the dose level by an independent Data and Safety Monitoring Board and Trial Steering Commitee.
Participants will continue to be monitored in the Neonatal Unit until discharge.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0381
Date of REC Opinion
21 Jun 2023
REC opinion
Further Information Favourable Opinion