Transient Tachypnea of the NewbornPATETNCT02965365
PATET Ratio to Rule Out Transient Tachypnea of the Newborn
An observational study of Transient Tachypnea of the Newborn, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can be predicted via evaluating pulmonary artery Doppler indices. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transient Tachypnea of the Newborn
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Oct 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Singleton pregnancies beyond 34 weeks gestational age, with no congenital fetal abnormalities and without any chronicle maternal disease or pregnancy complication like gestational diabetes, preeclampsia, etc. were included in the study.
Who may be able to join
- Singleton pregnancies who delivered beyond 34 weeks gestational age
Who cannot join
- fetal abnormality, chronicle maternal disease, pregnancy complication (preeclampsia, diabetes, intrauterine growth restriction,etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-invasive Method To Rule Out Transient Tachypnea of the Newborn (TTN) : Pulmonary Artery Acceleration to Ejection Time Ratio
This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can be predicted via evaluating pulmonary artery Doppler indices.
Read the detailed description
Transient Tachypnea of the Newborn(TTN) is the most common diagnosed disease in state of neonatal respiratory distress. However there is not an adequate method to diagnose or rule out TTN.
In several studies pulmonary artery Doppler indices are investigated as the possible indicators of pulmonary function. As a result of these studies, physiological processes in fetal lung maturation were established; pulmonary tissue impedance or resistance decreases with increasing gestational age, leading to increased pulmonary blood flow. In a normal lung maturation process the peak sistolic velocity is reached in midsystole, but in case of any reason disturbing the nornal development process,the peak occurs earlier.
We suggested that TTN, which is a factor increasing pulmonary tissue impedance like respiratory distress syndrome(RDS) and pulmonary hypoplasia, would change pulmonary artery(PA) Doppler indices, thus by the way of evaluating pulmonary artery Doplerr indices, we could predict possible diagnosis of TTN
- Conditions
- Transient Tachypnea of the Newborn
- Medical subject headings
- Transient Tachypnea of the Newborn
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 |
|---|---|---|
| TTN positive group | The group which subsequently diagnosed as TTN | |
| TTN negative group | The group which is not diagnosed as TTN |
What is being measured
The primary outcome is the main question the study is designed to answer.
PATET ratio
pulmonary artery acceleration to ejection time ratio
Measured: 5 minutes
Secondary outcomes (1)
PA PI
pulmonary artery pulsatility index
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Transient Tachypnea of the NewbornStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hatice Akkaya, Kayseri Education and Research Hospital
- Investigators
- Barış Büke, resident, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965365
- Sponsor's protocol ID
- E52332816_54
- Acronym
- PATET
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data belonging to participants, will be available to any researcher or editorial review board if needed.
Publications
Guglani L, Lakshminrusimha S, Ryan RM. Transient tachypnea of the newborn. Pediatr Rev. 2008 Nov;29(11):e59-65. doi: 10.1542/pir.29-11-e59. No abstract available.
PubMed 18977854Demirel G, Uras N, Celik IH, Canpolat FE, Dilmen U. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for transient tachypnea of newborn: a randomized, prospective study. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1099-102. doi: 10.3109/14767058.2013.766707. Epub 2013 Feb 27.
PubMed 23419098Avery ME, Gatewood OB, Brumley G. Transient tachypnea of newborn. Possible delayed resorption of fluid at birth. Am J Dis Child. 1966 Apr;111(4):380-5. doi: 10.1001/archpedi.1966.02090070078010. No abstract available.
PubMed 5906048Tudehope DI, Smyth MH. Is "transient tachypnoea of the newborn" always a benign disease? Report of 6 babies requiring mechanical ventilation. Aust Paediatr J. 1979 Sep;15(3):160-5. doi: 10.1111/j.1440-1754.1979.tb01215.x. No abstract available.
PubMed 518409Kugelman A, Riskin A, Weinger-Abend M, Bader D. Familial neonatal pneumothorax associated with transient tachypnea of the newborn. Pediatr Pulmonol. 2003 Jul;36(1):69-72. doi: 10.1002/ppul.10283.
PubMed 12772227Rasanen J, Huhta JC, Weiner S, Wood DC, Ludomirski A. Fetal branch pulmonary arterial vascular impedance during the second half of pregnancy. Am J Obstet Gynecol. 1996 May;174(5):1441-9. doi: 10.1016/s0002-9378(96)70586-0.
PubMed 9065109Chaoui R, Taddei F, Rizzo G, Bast C, Lenz F, Bollmann R. Doppler echocardiography of the main stems of the pulmonary arteries in the normal human fetus. Ultrasound Obstet Gynecol. 1998 Mar;11(3):173-9. doi: 10.1046/j.1469-0705.1998.11030173.x.
PubMed 9589139Kitabatake A, Inoue M, Asao M, Masuyama T, Tanouchi J, Morita T, Mishima M, Uematsu M, Shimazu T, Hori M, Abe H. Noninvasive evaluation of pulmonary hypertension by a pulsed Doppler technique. Circulation. 1983 Aug;68(2):302-9. doi: 10.1161/01.cir.68.2.302.
PubMed 6861308Chaoui R, Kalache K, Tennstedt C, Lenz F, Vogel M. Pulmonary arterial Doppler velocimetry in fetuses with lung hypoplasia. Eur J Obstet Gynecol Reprod Biol. 1999 Jun;84(2):179-85. doi: 10.1016/s0301-2115(98)00327-3.
PubMed 10428341Kim SM, Park JS, Norwitz ER, Hwang EJ, Kang HS, Park CW, Jun JK. Acceleration time-to-ejection time ratio in fetal pulmonary artery predicts the development of neonatal respiratory distress syndrome: a prospective cohort study. Am J Perinatol. 2013 Nov;30(10):805-12. doi: 10.1055/s-0032-1333132. Epub 2013 Jan 4.
PubMed 23292917Guan 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 25110859Rizzo G, Capponi A, Angelini E, Mazzoleni A, Romanini C. Blood flow velocity waveforms from fetal peripheral pulmonary arteries in pregnancies with preterm premature rupture of the membranes: relationship with pulmonary hypoplasia. Ultrasound Obstet Gynecol. 2000 Feb;15(2):98-103. doi: 10.1046/j.1469-0705.2000.00006.x.
PubMed 10775989Rawlings JS, Smith FR. Transient tachypnea of the newborn. An analysis of neonatal and obstetric risk factors. Am J Dis Child. 1984 Sep;138(9):869-71. doi: 10.1001/archpedi.1984.02140470067022.
PubMed 6540983Clark SL, Meyers JA, Perlin JB. Oversight of elective early term deliveries: avoiding unintended consequences. Am J Obstet Gynecol. 2012 May;206(5):387-9. doi: 10.1016/j.ajog.2011.08.017. Epub 2011 Aug 22.
PubMed 21963311Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2013. Natl Vital Stat Rep. 2015 Jan 15;64(1):1-65.
PubMed 25603115
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-invasive Method To Rule Out Transient Tachypnea of the Newborn (TTN) : Pulmonary Artery Acceleration to Ejection Time Ratio
- ClinicalTrials.gov ID
- NCT02965365
- Acronym / sponsor ID
- PATET / E52332816_54
- Conditions
- Transient Tachypnea of the Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Nov 2016 (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.
This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can be predicted via evaluating pulmonary artery Doppler indices.
Detailed description
Transient Tachypnea of the Newborn(TTN) is the most common diagnosed disease in state of neonatal respiratory distress. However there is not an adequate method to diagnose or rule out TTN.
In several studies pulmonary artery Doppler indices are investigated as the possible indicators of pulmonary function. As a result of these studies, physiological processes in fetal lung maturation were established; pulmonary tissue impedance or resistance decreases with increasing gestational age, leading to increased pulmonary blood flow. In a normal lung maturation process the peak sistolic velocity is reached in midsystole, but in case of any reason disturbing the nornal development process,the peak occurs earlier.
We suggested that TTN, which is a factor increasing pulmonary tissue impedance like respiratory distress syndrome(RDS) and pulmonary hypoplasia, would change pulmonary artery(PA) Doppler indices, thus by the way of evaluating pulmonary artery Doplerr indices, we could predict possible diagnosis of TTN
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTN positive group | – | –The group which subsequently diagnosed as TTN |
| TTN negative group | – | –The group which is not diagnosed as TTN |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singleton pregnancies beyond 34 weeks gestational age, with no congenital fetal abnormalities and without any chronicle maternal disease or pregnancy complication like gestational diabetes, preeclampsia, etc. were included in the study.
Key inclusion criteria (1 listed)
- Singleton pregnancies who delivered beyond 34 weeks gestational age
Key exclusion criteria (1 listed)
- fetal abnormality, chronicle maternal disease, pregnancy complication (preeclampsia, diabetes, intrauterine growth restriction,etc.)
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
PATET ratio
Time frame: 5 minutes
pulmonary artery acceleration to ejection time ratio
1 secondary outcome
PA PI
Time frame: 2 minutes
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 17 Nov 2016.
- Background: PubMed 18977854Guglani L, Lakshminrusimha S, Ryan RM. Transient tachypnea of the newborn. Pediatr Rev. 2008 Nov;29(11):e59-65. doi: 10.1542/pir.29-11-e59. No abstract available.
- Background: PubMed 23419098Demirel G, Uras N, Celik IH, Canpolat FE, Dilmen U. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for transient tachypnea of newborn: a randomized, prospective study. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1099-102. doi: 10.3109/14767058.2013.766707. Epub 2013 Feb 27.
- Background: PubMed 5906048Avery ME, Gatewood OB, Brumley G. Transient tachypnea of newborn. Possible delayed resorption of fluid at birth. Am J Dis Child. 1966 Apr;111(4):380-5. doi: 10.1001/archpedi.1966.02090070078010. No abstract available.
- Background: PubMed 518409Tudehope DI, Smyth MH. Is "transient tachypnoea of the newborn" always a benign disease? Report of 6 babies requiring mechanical ventilation. Aust Paediatr J. 1979 Sep;15(3):160-5. doi: 10.1111/j.1440-1754.1979.tb01215.x. No abstract available.
- Background: PubMed 12772227Kugelman A, Riskin A, Weinger-Abend M, Bader D. Familial neonatal pneumothorax associated with transient tachypnea of the newborn. Pediatr Pulmonol. 2003 Jul;36(1):69-72. doi: 10.1002/ppul.10283.
- Background: PubMed 9065109Rasanen J, Huhta JC, Weiner S, Wood DC, Ludomirski A. Fetal branch pulmonary arterial vascular impedance during the second half of pregnancy. Am J Obstet Gynecol. 1996 May;174(5):1441-9. doi: 10.1016/s0002-9378(96)70586-0.
- Background: PubMed 9589139Chaoui R, Taddei F, Rizzo G, Bast C, Lenz F, Bollmann R. Doppler echocardiography of the main stems of the pulmonary arteries in the normal human fetus. Ultrasound Obstet Gynecol. 1998 Mar;11(3):173-9. doi: 10.1046/j.1469-0705.1998.11030173.x.
- Background: PubMed 6861308Kitabatake A, Inoue M, Asao M, Masuyama T, Tanouchi J, Morita T, Mishima M, Uematsu M, Shimazu T, Hori M, Abe H. Noninvasive evaluation of pulmonary hypertension by a pulsed Doppler technique. Circulation. 1983 Aug;68(2):302-9. doi: 10.1161/01.cir.68.2.302.
- Background: PubMed 10428341Chaoui R, Kalache K, Tennstedt C, Lenz F, Vogel M. Pulmonary arterial Doppler velocimetry in fetuses with lung hypoplasia. Eur J Obstet Gynecol Reprod Biol. 1999 Jun;84(2):179-85. doi: 10.1016/s0301-2115(98)00327-3.
- Background: PubMed 23292917Kim SM, Park JS, Norwitz ER, Hwang EJ, Kang HS, Park CW, Jun JK. Acceleration time-to-ejection time ratio in fetal pulmonary artery predicts the development of neonatal respiratory distress syndrome: a prospective cohort study. Am J Perinatol. 2013 Nov;30(10):805-12. doi: 10.1055/s-0032-1333132. Epub 2013 Jan 4.
- 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.
- Background: PubMed 10775989Rizzo G, Capponi A, Angelini E, Mazzoleni A, Romanini C. Blood flow velocity waveforms from fetal peripheral pulmonary arteries in pregnancies with preterm premature rupture of the membranes: relationship with pulmonary hypoplasia. Ultrasound Obstet Gynecol. 2000 Feb;15(2):98-103. doi: 10.1046/j.1469-0705.2000.00006.x.
- Individual participant dataSharing planned: Yes. The data belonging to participants, will be available to any researcher or editorial review board if needed.
Related trials for Transient Tachypnea of the Newborn
RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruitingObservational study
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Diastolic Dysfunction, Neonatal Encephalopathy
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
Not yet recruiting
The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN
Active, not recruitingPhase 3
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
TTN, Respiratory Failure
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.
Barış Büke, resident principal investigator
Kayseri Education and Research 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 Transient Tachypnea of the Newborn, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
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 17 Nov 2016. 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 Turkey (Türkiye). 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?
PATET ratio (time frame: 5 minutes). 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 NCT02965365, which also lists 22 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 17 Nov 2016.