Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed DopplerNCT02283138
Prediction of Neonatal Respiratory Distress Syndrome in Preterm Fetuses by Assessment of Fetal Lung Volume by Vocal and Pulmonary Artery Resistance Index a Pilot Study
An observational study of Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed Doppler, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance index in preterm fetuses and correlating the results with postnatal respiratory distress of the preterm neonates. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed Doppler
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2014to Jul 2017
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at 28 to 34 weeks gestation
Who may be able to join
- preterm labour
Who cannot join
- twins
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance index in preterm fetuses and correlating the results with postnatal respiratory distress of the preterm neonates.
- Keywords
- FLV, VOCAL, PA-RI, preterm fetuses, RDS
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal respiratory distress
Apgar score at birth, need for NICU admission after delivery, need for neonate with RDS for continuous positive airway pressure ventilation
Measured: at time of delivery
Secondary outcomes (1)
Neonatal mortality rate
Follow up for early neonatal mortality rate after NICU admission ,
Measured: One week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed DopplerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283138
- Sponsor's protocol ID
- lab7680
- Status last verified
- Jul 2017
- First submitted
- 31 Oct 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Neonatal Respiratory Distress Syndrome in Preterm Fetuses by Assessment of Fetal Lung Volume by Vocal and Pulmonary Artery Resistance Index a Pilot Study
- ClinicalTrials.gov ID
- NCT02283138
- Acronym / sponsor ID
- lab7680
- Keywords
- FLV, VOCAL, PA-RI, preterm fetuses, RDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Study start
- Nov 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Nov 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 investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance index in preterm fetuses and correlating the results with postnatal respiratory distress of the preterm neonates.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at 28 to 34 weeks gestation
Key inclusion criteria (1 listed)
- preterm labour
Key exclusion criteria (1 listed)
- twins
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
Neonatal respiratory distress
Time frame: at time of delivery
Apgar score at birth, need for NICU admission after delivery, need for neonate with RDS for continuous positive airway pressure ventilation
1 secondary outcome
Neonatal mortality rate
Time frame: One week after delivery
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 18 Jul 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed Doppler, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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 18 Jul 2017. 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 Egypt. 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?
Neonatal respiratory distress (time frame: at time of delivery). 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 18 Jul 2017.