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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroids | Experimental | Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram) |
|
| Placebo | Placebo Comparator | Patients will receive nebulized 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled corticosteroids | Other | Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of respiratory distress | Transient tachypnea of the newborn clinical score | within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of time to spontaneous breathing | Time to spontaneous unsupported breathing of room air (in hours) | with 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sirin Mneimneh, MD | Contact | +9611636000 | 6317 | sirin.mneimneh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sirin Mneimneh, MD | Makassed General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Recruiting | Beirut | +961 | Lebanon |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Placebo | Other | Nebulized 0.9% saline will be given four times per day |
|
| D013568 | Pathological Conditions, Signs and Symptoms |