- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149928
Role of Cord Blood Hormones and Epinephrine in the Development of Transient Tachypnea of the Newborn
June 23, 2010 updated by: Ankara University
In this prospective, cross-sectional study, the aim was to investigate the possible role of cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4, and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
70
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
7 months to 9 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Cesarean delivered, late preterm and term infants during the study period in Maternity Center of Ankara University
Description
Inclusion Criteria:
- Gestation age > 34 weeks
- C/S delivered infants
- Parental consent form signed
Exclusion Criteria:
- Gestation age < 34 weeks
- Maternal conditions that compromised fetal well-being (hypertensive disorder, diabetes, chorioamnionitis)
- Intrauterine growth retardation
- Congenital malformations
- Absence of parental consent
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 |
---|
C/S delivered, wet lung
|
C/S delivered, healthy infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress response at birth, as demonstrated by cord cortisol, adrenocorticotropic hormone, epinephrine, fT3, fT4, and thyroid-stimulating hormone in late preterm and term neonates developing transient tachypnea of the newborn.
Time Frame: postnatal first 24 hours
|
At birth cord blood samples and perinatal data were collected from ceseraen deliveries of late preterm and term infants.
Cord stress hormones of the infants with the diagnosis of TTN and gestational age matched controls were analyzed.
|
postnatal first 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
September 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
June 21, 2010
First Submitted That Met QC Criteria
June 23, 2010
First Posted (Estimate)
June 24, 2010
Study Record Updates
Last Update Posted (Estimate)
June 24, 2010
Last Update Submitted That Met QC Criteria
June 23, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08H3330006
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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