Inhaled Budesonide in Transient Tachypnea of the Newborn

Study Overview
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Brief Summary
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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

Official Title
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Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study

Conditions
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Respiratory Distress

Intervention / Treatment
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* Other: Inhaled corticosteroids
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroids<br>Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram) | Other: Inhaled corticosteroids<br>* Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours<br>|
| Placebo Comparator: Placebo<br>Patients will receive nebulized 0.9% saline | Other: Placebo<br>* Nebulized 0.9% saline will be given four times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of respiratory distress | Transient tachypnea of the newborn clinical score | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of time to spontaneous breathing | Time to spontaneous unsupported breathing of room air (in hours) | with 48 hours |