Wet Lung Clinical Trial
| Verified date | October 2009 |
| Source | Ankara University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | October 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 34 Weeks to 40 Weeks |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ankara University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | postnatal first 24 hours | No |