Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)

RDS Clinical Trial

Official title:

Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008200
• Other study ID #: KayseriEAH
• Status: Completed
• Phase: N/A
• First received: December 20, 2016
• Last updated: December 31, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: December 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

Fetal PATET ratio evaluation to predict neonatal RDS

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregnant women within the 27 weeks of gestation and beyond

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• RDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• ultrasound examination
intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

References & Publications (3)

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ten months	No