RDSNCT02076126
Determination of Lung Maturity and Prediction of RDS at Birth
An observational study of RDS and Premature Birth, run by Henrik Axel Verder at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 30 minutes
- Conditions the study is for
- RDS, Premature Birth
- How many people
- 145 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 30 minutes
- All sexes
- No healthy volunteers
- Child
Study population: 135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)
Who may be able to join
- Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
- Age < ½ hour
Who cannot join
- Lack of informed consent
- lack of aspirate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- Lung maturity, RDS, Prematurity, Lecithin-sphingomyelin ratio, Spectroscopy, Chemometrics
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
RDS
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Axel Verder
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus, Aalborg University Hospital, Odense University Hospital, Aarhus University Hospital Skejby, Kolding Sygehus, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Naestved Hospital, University Hospital, Linkoeping, Skane University Hospital
- Responsible party
- Sponsor-investigator, Henrik Axel Verder, Holbaek Sygehus
- Investigators
- Henrik Verder, Professor MD, Principal investigator, Holbaek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076126
- Sponsor's protocol ID
- Holb.SJ-384
- Status last verified
- Jan 2015
- First submitted
- 28 Feb 2014
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS
- ClinicalTrials.gov ID
- NCT02076126
- Acronym / sponsor ID
- Holb.SJ-384
- Conditions
- RDS, Premature Birth
- Keywords
- Lung maturity, RDS, Prematurity, Lecithin-sphingomyelin ratio, Spectroscopy, Chemometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Henrik Axel VerderUniversity, hospital or other
- Collaborators
- Holbaek Sygehus, Aalborg University Hospital, Odense University Hospital, Aarhus University Hospital Skejby, Kolding Sygehus, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Naestved Hospital, University Hospital, Linkoeping, Skane University Hospital
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 minute to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)
Key inclusion criteria (2 listed)
- Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
- Age < ½ hour
Key exclusion criteria (2 listed)
- Lack of informed consent
- lack of aspirate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RDS
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Verder, Professor MD principal investigator
Holbaek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RDS and Premature Birth, run by Henrik Axel Verder at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RDS (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.