Wet LungNCT01149928
Role of Cord Blood Hormones and Epinephrine in the Development of Transient Tachypnea of the Newborn
An observational study of Wet Lung, run by Ankara University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 34 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Wet Lung
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2009
- 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 34 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cesarean delivered, late preterm and term infants during the study period in Maternity Center of Ankara University
Who may be able to join
- Gestation age > 34 weeks
- C/S delivered infants
- Parental consent form signed
Who cannot join
- Gestation age < 34 weeks
- Maternal conditions that compromised fetal well-being (hypertensive disorder, diabetes, chorioamnionitis)
- Intrauterine growth retardation
- Congenital malformations
- Absence of parental consent
About this study
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.
- Conditions
- Wet Lung
- Keywords
- Fetal lung fluid, Pulmonary adaptation, Transient tachypnea of the newborn, Epinephrine, Stress hormones
- Medical subject headings
- Pulmonary Edema, Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| C/S delivered, wet lung | Not described | |
| C/S delivered, healthy infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: postnatal first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionOct 2009
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 Wet LungStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149928
- Sponsor's protocol ID
- 08H3330006
- Status last verified
- Oct 2009
- First submitted
- 21 Jun 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Atasay B, Ergun H, Okulu E, Mungan Akin I, Arsan S. The association between cord hormones and transient tachypnea of newborn in late preterm and term neonates who were delivered by cesarean section. J Matern Fetal Neonatal Med. 2013 Jun;26(9):877-80. doi: 10.3109/14767058.2013.765846. Epub 2013 Feb 8.
PubMed 23311764
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cord Blood Hormones and Epinephrine in the Development of Transient Tachypnea of the Newborn
- ClinicalTrials.gov ID
- NCT01149928
- Acronym / sponsor ID
- 08H3330006
- Conditions
- Wet Lung
- Keywords
- Fetal lung fluid, Pulmonary adaptation, Transient tachypnea of the newborn, Epinephrine, Stress hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Jun 2010 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C/S delivered, wet lung | – | – |
| C/S delivered, healthy infants | – | – |
Who may qualify
- Ages
- 34 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cesarean delivered, late preterm and term infants during the study period in Maternity Center of Ankara University
Key inclusion criteria (3 listed)
- Gestation age > 34 weeks
- C/S delivered infants
- Parental consent form signed
Key exclusion criteria (5 listed)
- Gestation age < 34 weeks
- Maternal conditions that compromised fetal well-being (hypertensive disorder, diabetes, chorioamnionitis)
- Intrauterine growth retardation
- Congenital malformations
- Absence of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 24 Jun 2010.
- Derived from this study: PubMed 23311764Atasay B, Ergun H, Okulu E, Mungan Akin I, Arsan S. The association between cord hormones and transient tachypnea of newborn in late preterm and term neonates who were delivered by cesarean section. J Matern Fetal Neonatal Med. 2013 Jun;26(9):877-80. doi: 10.3109/14767058.2013.765846. Epub 2013 Feb 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Lung, run by Ankara University.
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 3 inclusion and 5 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 24 Jun 2010. 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?
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). 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 NCT01149928, 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 24 Jun 2010.