PATET Ratio to Rule Out Transient Tachypnea of the Newborn

Transient Tachypnea of the Newborn Clinical Trial

— PATET  

Official title:

A Non-invasive Method To Rule Out Transient Tachypnea of the Newborn (TTN) : Pulmonary Artery Acceleration to Ejection Time Ratio

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965365
• Other study ID #: E52332816_54
• Status: Completed
• Phase: N/A
• First received: November 13, 2016
• Last updated: November 16, 2016
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancies who delivered beyond 34 weeks gestational age

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn

Locations

Country	Name	City	State
Turkey	Kayseri Dogumevi	Kocasinan	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

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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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PATET ratio	pulmonary artery acceleration to ejection time ratio	5 minutes	Yes
Secondary	PA PI	pulmonary artery pulsatility index	2 minutes	Yes