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

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02813954
• Collaborator: (none)
• Enrollment: 184
• Duration (Months): 8

Study Details

Study Description

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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 184 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 25 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 27, 2016
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiration Disorders; Respiratory Tract Diseases; Tachypnea; Transient Tachypnea of the Newborn

Study Results

No Results Posted as of Aug 18, 2022