Determination of Lung Maturity and Prediction of RDS at Birth

January 29, 2015 updated by: Henrik Axel Verder

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holbaek, Denmark, 4300
        • Holbaek Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 30 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Gastric aspirate
L/S ratio on the gastric aspirates are retrospectively compared with the possible development of RDS
Hypopharyngeal secretion
L/S ratio on the hypopharyngeal secretions are retrospectively compared with the possible development of RDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RDS
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henrik Axel Verder

Collaborators

Odense University Hospital
Aarhus University Hospital Skejby
Rigshospitalet, Denmark
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
University Hospital, Linkoeping
Aalborg University Hospital
Holbaek Sygehus
Skane University Hospital
Naestved Hospital
Kolding Sygehus

Investigators

  • Principal Investigator: Henrik Verder, Professor MD, Holbaek Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Holb.SJ-384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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