Determination of Lung Maturity and Prediction of RDS at Birth

Completed

• Conditions: Premature Birth; RDS

• Registration Number: NCT02076126
• Lead Sponsor: Henrik Axel Verder

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-02-28
• Study Start: 2014-03
• Study First Posted: 2014-03-03
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
• Age < ½ hour

Exclusion Criteria

• Lack of informed consent
• lack of aspirate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RDS	5 days

Trial Locations

Locations (1)

Holbaek Sygehus; 🇩🇰 Holbaek, Denmark