Premature Birth Clinical Trial
Official title:
Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS
Verified date | January 2015 |
Source | Holbaek Sygehus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 30 Minutes |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Denmark | Holbaek Sygehus | Holbaek |
Lead Sponsor | Collaborator |
---|---|
Henrik Axel Verder | Aalborg Universitetshospital, Aarhus University Hospital Skejby, Copenhagen University Hospital at Herlev, Holbaek Sygehus, Hvidovre University Hospital, Kolding Sygehus, Naestved Hospital, Odense University Hospital, Rigshospitalet, Denmark, Skane University Hospital, University Hospital, Linkoeping |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RDS | 5 days | No |
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