Respiratory Distress SyndromeNCT02813954
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
An observational study of Respiratory Distress Syndrome and Transient Tachypnea of Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 hoursHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Transient Tachypnea of Newborn
- What is being tested?
- Blood Gas Sampling
- Type of treatment
- Medical device
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Apr 2016
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Accepted to participate with informed consent Normal healthy pregnancies
Who cannot join
- Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate
About this study
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.
- Being tested
- Blood Gas Sampling
- Medical subject headings
- Respiratory Distress Syndrome, Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Gas SamplingDevice
analyzing amniotic fluid by blood gas device
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Neonates with respiratory distress Receives: Device: Blood Gas Sampling | |
| Control Group | Healthy Infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Seda Yilmaz Semerci, Principal investigator, Postdoctoral Fellow of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813954
- Sponsor's protocol ID
- 12
- Status last verified
- Aug 2022
- First submitted
- 22 Jun 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30033781
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
- ClinicalTrials.gov ID
- NCT02813954
- Acronym / sponsor ID
- 12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Blood Gas SamplingNeonates with respiratory distress |
| Control Group | – | –Healthy Infants |
Who may qualify
- Ages
- Up to 25 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Accepted to participate with informed consent Normal healthy pregnancies
Key exclusion criteria (1 listed)
- Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Gas Samplinganalyzing amniotic fluid by blood gas device | Device | Study Group |
Primary outcome
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 30033781Yilmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Yilmaz Semerci principal investigator
Postdoctoral Fellow of Neonatology
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Transient Tachypnea of Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.