The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

August 16, 2022 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. While fetal urine is the major content of AF since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL depends on chloride transport and postnatal clearance of FLL is provided by active reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. Lower genomic expression of Na channels in airways is shown to be associated to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

184

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

No older than 1 day (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Accepted to participate with informed consent Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Neonates with respiratory distress
Device: Blood Gas Sampling
analyzing amniotic fluid by blood gas device
Control Group
Healthy Infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Seda Yilmaz Semerci, Postdoctoral Fellow of Neonatology

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

August 1, 2015

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 (Israel lung Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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