PATET Ratio to Rule Out Transient Tachypnea of the Newborn (PATET)

November 16, 2016 updated by: Hatice Akkaya, Kayseri Education and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Transient Tachypnea of the Newborn

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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- Kayseri
  - Kocasinan, Kayseri, Turkey, 38090
    - Kayseri Doğumevi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
TTN positive group The group which subsequently diagnosed as TTN
TTN negative group The group which is not diagnosed as TTN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PATET ratio Time Frame: 5 minutes	pulmonary artery acceleration to ejection time ratio	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PA PI Time Frame: 2 minutes	pulmonary artery pulsatility index	2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri Education and Research Hospital

Investigators

Principal Investigator: Barış Büke, resident, Kayseri Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria