RDSNCT03008200
Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)
An observational study of RDS, run by Kayseri Education and Research Hospital.
Trial summary
Fetal PATET ratio evaluation to predict neonatal RDS Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- RDS
- What is being tested?
- ultrasound examination
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women beyond 27 weeks
Who may be able to join
- pregnant women within the 27 weeks of gestation and beyond
Who cannot join
- patients who did not give birth within 3 days after the ultrasonographic doppler examination
- fetuses with Any congenital abnormalities
- amniotic fluid abnormalities
- any chronic maternal diseases or pregnancy complications such as;gestational diabetes mellitus,preeclampsia
About this study
Fetal PATET ratio evaluation to predict neonatal RDS
Read the detailed description
115 patients were enrolled in this study.Population was recruited from singleton pregnancies beyond 27 weeks of gestation.All participants underwent a ultrasound examination to measure fetal pulmonary artery acceleration to ejection time ratio (PATET) by a single experienced clinician. After the delivery respiratory distress diagnosis made by a pediatrician who were blinded the doppler waveform measurements.Following the diagnosis, neonates divided into 2 groups as RDS (+) and RDS (-). In addition of RDS diagnosis, neonatal features like 1st and 5th minute APGAR scores, neonatal intensive care unit (NICU) admission and duration in NICU were also recorded. Afterwards all parameters were statistically analyzed if there is any significant differences between those two groups.
- Conditions
- RDS
- Being tested
- ultrasound examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationDevice
intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound
| Study group | Role | What they receive |
|---|---|---|
| RDS + | postpartum RDS developed group Receives: Device: ultrasound examination | |
| RDS - | postpartum RDS undeveloped group Receives: Device: ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome
The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Destegül, Kayseri Education and Research Hospital
- Investigators
- Barıs Buke, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008200
- Sponsor's protocol ID
- KayseriEAH
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: if necessary
Publications
Schenone MH, Samson JE, Jenkins L, Suhag A, Mari G. Predicting fetal lung maturity using the fetal pulmonary artery Doppler wave acceleration/ejection time ratio. Fetal Diagn Ther. 2014;36(3):208-14. doi: 10.1159/000358299. Epub 2014 Aug 13.
PubMed 25139576Azpurua H, Norwitz ER, Campbell KH, Funai EF, Pettker CM, Kleine M, Bahtiyar MO, Malkus H, Copel JA, Thung SF. Acceleration/ejection time ratio in the fetal pulmonary artery predicts fetal lung maturity. Am J Obstet Gynecol. 2010 Jul;203(1):40.e1-8. doi: 10.1016/j.ajog.2010.01.075. Epub 2010 Apr 24.
PubMed 20417479Guan Y, Li S, Luo G, Wang C, Norwitz ER, Fu Q, Tu X, Tian X, Zhu J. The role of doppler waveforms in the fetal main pulmonary artery in the prediction of neonatal respiratory distress syndrome. J Clin Ultrasound. 2015 Jul-Aug;43(6):375-83. doi: 10.1002/jcu.22219. Epub 2014 Aug 11.
PubMed 25110859
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)
- ClinicalTrials.gov ID
- NCT03008200
- Acronym / sponsor ID
- KayseriEAH
- Conditions
- RDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jan 2017 (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.
Fetal PATET ratio evaluation to predict neonatal RDS
Detailed description
115 patients were enrolled in this study.Population was recruited from singleton pregnancies beyond 27 weeks of gestation.All participants underwent a ultrasound examination to measure fetal pulmonary artery acceleration to ejection time ratio (PATET) by a single experienced clinician. After the delivery respiratory distress diagnosis made by a pediatrician who were blinded the doppler waveform measurements.Following the diagnosis, neonates divided into 2 groups as RDS (+) and RDS (-). In addition of RDS diagnosis, neonatal features like 1st and 5th minute APGAR scores, neonatal intensive care unit (NICU) admission and duration in NICU were also recorded. Afterwards all parameters were statistically analyzed if there is any significant differences between those two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDS + | – | Device: ultrasound examinationpostpartum RDS developed group |
| RDS - | – | Device: ultrasound examinationpostpartum RDS undeveloped group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women beyond 27 weeks
Key inclusion criteria (1 listed)
- pregnant women within the 27 weeks of gestation and beyond
Key exclusion criteria (4 listed)
- patients who did not give birth within 3 days after the ultrasonographic doppler examination
- fetuses with Any congenital abnormalities
- amniotic fluid abnormalities
- any chronic maternal diseases or pregnancy complications such as;gestational diabetes mellitus,preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound examinationintrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound | Device | RDS +, RDS - |
Primary outcome
Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome
Time frame: Ten months
The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation
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 4 Jan 2017.
- Background: PubMed 25139576Schenone MH, Samson JE, Jenkins L, Suhag A, Mari G. Predicting fetal lung maturity using the fetal pulmonary artery Doppler wave acceleration/ejection time ratio. Fetal Diagn Ther. 2014;36(3):208-14. doi: 10.1159/000358299. Epub 2014 Aug 13.
- Background: PubMed 20417479Azpurua H, Norwitz ER, Campbell KH, Funai EF, Pettker CM, Kleine M, Bahtiyar MO, Malkus H, Copel JA, Thung SF. Acceleration/ejection time ratio in the fetal pulmonary artery predicts fetal lung maturity. Am J Obstet Gynecol. 2010 Jul;203(1):40.e1-8. doi: 10.1016/j.ajog.2010.01.075. Epub 2010 Apr 24.
- Background: PubMed 25110859Guan Y, Li S, Luo G, Wang C, Norwitz ER, Fu Q, Tu X, Tian X, Zhu J. The role of doppler waveforms in the fetal main pulmonary artery in the prediction of neonatal respiratory distress syndrome. J Clin Ultrasound. 2015 Jul-Aug;43(6):375-83. doi: 10.1002/jcu.22219. Epub 2014 Aug 11.
- Individual participant dataSharing planned: Yes. if necessary
Related trials for RDS
RecruitingObservational study
Respiratory Distress and Elective Cesarean Section at Term
Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
RecruitingObservational study
Pulse Wave vs. Saline Contrast EIT for Pulmonary Perfusion in ARDS
ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT)
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
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.
Barıs Buke principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of RDS, run by Kayseri Education and Research Hospital.
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 4 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome (time frame: Ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008200, which also lists 3 linked publications.
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 4 Jan 2017.