Baby Lung: an observational study.
Research type
Research Study
Full title
Inflammatory markers and Surfactant Proteins in preterm infants at risk of developing chronic lung disease: an observational study.
IRAS ID
292480
Contact name
Reena Bhatt
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2021/02/46 , Data Protection registration
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Neonatal chronic lung disease [CLD] affects 50-60% of babies that are born between 23 and 30 weeks of pregnancy [also known as gestation]. It is usually defined by the need for oxygen past 36 weeks corrected gestational age. The cause of CLD is not completely known but we do know that development of the lungs, infection, inflammation damage by oxygen and ventilation play a role.
Baby Lung is a single centre observational study which aims to look at markers of the immune system that play a role in causing CLD in premature babies. In Baby lung we will be looking specifically at surfactant protein D [SP-D] and its relationship with proteins [cytokines] and cells that are part of the inflammatory response. Studies on lambs and mice have shown that SP-D plays an important role in preventing the inflammation and we know from previous studies in preterm babies that levels are low at birth in these babies who are at highest risk of CLD. This will provide vital information about the interaction and relationships between factors affecting the baby such as maternal infection on levels of SP-D and the inflammatory proteins. This study is the first stage in generating a reference group for subsequent intervention studies using SP-D. All babies born at the study site between 23 weeks and 0 days to 30 weeks and 0 days will be able to participate. The study will take place at an NHS hospital with a neonatal intensive care. All participants will be part of the study until they are at the equivalent of 36 weeks of pregnancy [36 weeks post conceptual age].We expect recruitment to last for 12 months from when we are able to open the study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0152
Date of REC Opinion
1 Jul 2021
REC opinion
Further Information Favourable Opinion