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

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ClinicalTrials.gov Identifier: NCT02813954
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Transient Tachypnea of Newborn Device: Blood Gas Sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group
Neonates with respiratory distress
 Device: Blood Gas Sampling
analyzing amniotic fluid by blood gas device
No Intervention: Control Group
Healthy Infants


Outcome Measures
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Primary Outcome Measures :
  1. The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders [ Time Frame: 8 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Accepted to participate with informed consent Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813954


Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Principal Investigator: Seda Yilmaz Semerci Postdoctoral Fellow of Neonatology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seda Yilmaz Semerci, Postdoctoral Fellow of Neonatology, MD, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02813954    
Other Study ID Numbers: 12
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiration Disorders
Respiratory Tract Diseases
Tachypnea
 Transient Tachypnea of the Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory