Inhaled Budesonide in Transient Tachypnea of the Newborn (NCT04758078) | Clinical Trial Compass
UnknownNot Applicable
Inhaled Budesonide in Transient Tachypnea of the Newborn
Lebanon50 participantsStarted 2021-02-15
Plain-language summary
Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.
Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn
Who can participate
Age range
34 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
* Diagnosis of transient tachypnea of the newborn
* The need for Continuous positive airway pressure (CPAP) \>6 hours to obtain the oxygen saturation \>92%
Exclusion Criteria:
* Meconium aspiration syndrome;
* Respiratory distress syndrome
* Congenital heart Disease
* Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
* Pneumonia by chest x-ray
* Suspected sepsis/bacteremia
* Prenatal steroids
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.