Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05006235
Eligibility Criteria:
Inclusion Criteria:
* babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:
* Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth
* Persistence of tachypnea for at least 12 hours
* Mild cyanosis, nasal flaring, or retractions.
* Chest radiograph indicating at least one of the following:
* Prominent central vascular markings
* Widened interlobar fissures
* Symmetrical perihilar congestion
* Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.
Exclusion Criteria:
* Newborn infants with gestational age \< 35 weeks
* Meconium aspiration
* Respiratory distress syndrome
* Pneumonia
* Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
* Sepsis or suspected sepsis
* Polycythemia
* Newborn infants with congenital malformations and chromosomal anomalies
* Newborn infants with ventilatory support.
* Newborn infants with arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
6 Hours
Study:
NCT05006235
Study Brief:
Protocol Section:
NCT05006235