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

NCT02813954 | Completed DMC

• 1 other identifier: 12
• Study Type: observational
• Target: 184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Distress Syndrome; Transient Tachypnea of Newborn

Outcome Measures

Primary Outcomes (1)

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

  8 months

Study Arms (2)

Study Group

Neonates with respiratory distress

Device: Blood Gas Sampling

Control Group

Healthy Infants

Interventions

Blood Gas Sampling DEVICE

analyzing amniotic fluid by blood gas device

Study Group

Eligibility Criteria

• Age: Up to 25 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Accepted to participate with informed consent Normal healthy pregnancies

You may not qualify if:

• Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Related Publications (1)

• Yilmaz Semerci S, Yucel B, Erbas IM, Gunkaya OS, Talmac M, Cetinkaya M. The utility of amniotic fluid pH and electrolytes for prediction of neonatal respiratory disorders. J Matern Fetal Neonatal Med. 2020 Jan;33(2):253-257. doi: 10.1080/14767058.2018.1488961. Epub 2018 Jul 22.

  PMID: 30033781 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seda Yilmaz Semerci

  Postdoctoral Fellow of Neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow of Neonatology, MD

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 27, 2016
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share