NCT02076126

Determination of Lung Maturity and Prediction of RDS at Birth

Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 145 (actual)
• Sponsor: Henrik Axel Verder · Academic / Other
• Sex: All
• Age: 1 Minute – 30 Minutes
• Healthy volunteers: Not accepted

Summary

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment. We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Detailed description

In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks. The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy. The infants will be monitored for the first five days with regard to possible development of RDS. Clinical and biochemical data will be compared retrospectively. There a no intervention procedures.

Conditions

• RDS
• Premature Birth

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-03-03
• Last updated: 2015-01-30

Locations

1 site across 1 country: Denmark