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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02076126
Enrollment
145
Registered
2014-03-03
Start date
2014-03-31
Completion date
2015-01-31
Last updated
2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, RDS

Keywords

Lung maturity, RDS, Prematurity, Lecithin-sphingomyelin ratio, Spectroscopy, Chemometrics

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.

Interventions

None listed

Sponsors

Holbaek Sygehus
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Aarhus University Hospital Skejby
CollaboratorOTHER
Kolding Sygehus
CollaboratorOTHER
Copenhagen University Hospital at Herlev
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Naestved Hospital
CollaboratorOTHER
University Hospital, Linkoeping
CollaboratorOTHER
Skane University Hospital
CollaboratorOTHER
Henrik Axel Verder
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 30 Minutes
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
RDS5 days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026