PATET Ratio to Rule Out Transient Tachypnea of the Newborn

NCT02965365 | Completed

• 1 other identifier: E52332816_54
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transient Tachypnea of the Newborn

Outcome Measures

Primary Outcomes (1)

• PATET ratio

  pulmonary artery acceleration to ejection time ratio

  5 minutes

Secondary Outcomes (1)

• PA PI

  2 minutes

Study Arms (2)

TTN positive group

The group which subsequently diagnosed as TTN

TTN negative group

The group which is not diagnosed as TTN

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Singleton pregnancies who delivered beyond 34 weeks gestational age

You may not qualify if:

• fetal abnormality, chronicle maternal disease, pregnancy complication (preeclampsia, diabetes, intrauterine growth restriction,etc.)

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

Study Sites (1)

Kayseri Doğumevi

Kocasinan, Kayseri, 38090, Turkey (Türkiye)

Location

Related Publications (22)

• 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.

  PMID: 18977854 BACKGROUND

• Demirel 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.

  PMID: 23419098 BACKGROUND

• Avery 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.

  PMID: 5906048 BACKGROUND

• Tudehope 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.

  PMID: 518409 BACKGROUND

• Kugelman 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.

  PMID: 12772227 BACKGROUND

• Rasanen 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.

  PMID: 9065109 BACKGROUND

• Chaoui 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.

  PMID: 9589139 BACKGROUND

• Kitabatake 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.

  PMID: 6861308 BACKGROUND

• Chaoui 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.

  PMID: 10428341 BACKGROUND

• Kim 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.

  PMID: 23292917 BACKGROUND

• Guan 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.

  PMID: 25110859 BACKGROUND

• Rizzo 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.

  PMID: 10775989 BACKGROUND

• Rawlings 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.

  PMID: 6540983 BACKGROUND

• Clark 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.

  PMID: 21963311 BACKGROUND

• Martin 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.

  PMID: 25603115 BACKGROUND

• Statland BE, Sher G, Freer DE, Kraybill EN, Smith HY, Hisley JC. Evaluation of a modified foam stability (FS-50) test. An assay performed on amniotic fluid to predict fetal pulmonary maturity. Am J Clin Pathol. 1978 May;69(5):514-9. doi: 10.1093/ajcp/69.5.514. No abstract available.

  PMID: 655129 BACKGROUND

• Hagen E, Link JC, Arias F. A comparison of the accuracy of the TDx-FLM assay, lecithin-sphingomyelin ratio, and phosphatidylglycerol in the prediction of neonatal respiratory distress syndrome. Obstet Gynecol. 1993 Dec;82(6):1004-8.

  PMID: 8233250 BACKGROUND

• Tsuda H, Takahashi Y, Iwagaki S, Uchida Y, Kawabata I, Hayakawa M, Sumigama S, Hayakawa H, Kotani T, Kikkawa F. Amniotic lamellar body counts can predict the occurrence of respiratory distress syndrome as well as transient tachypnea of the newborn (TTN). J Perinat Med. 2011 May;39(3):245-50. doi: 10.1515/jpm.2011.006. Epub 2011 Feb 11.

  PMID: 21314236 BACKGROUND

• Machado MV, Chita SC, Allan LD. Acceleration time in the aorta and pulmonary artery measured by Doppler echocardiography in the midtrimester normal human fetus. Br Heart J. 1987 Jul;58(1):15-8. doi: 10.1136/hrt.58.1.15.

  PMID: 3620237 BACKGROUND

• Laudy JA, Gaillard JL, vd Anker JN, Tibboel D, Wladimiroff JW. Doppler ultrasound imaging: a new technique to detect lung hypoplasia before birth? Ultrasound Obstet Gynecol. 1996 Mar;7(3):189-92. doi: 10.1046/j.1469-0705.1996.07030189.x.

  PMID: 8705411 BACKGROUND

• Azpurua 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.

  PMID: 20417479 BACKGROUND

• 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.

  PMID: 25139576 BACKGROUND

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barış Büke, resident

  Kayseri Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)