Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makassed General Hospital
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Assessment of respiratory distress
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 34 Weeks to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Assessment of respiratory distress
Time Frame: within 48 hours
Transient tachypnea of the newborn clinical score
Secondary Outcomes
- Assessment of time to spontaneous breathing(with 48 hours)
Investigators
Dr. Sirin Mneimneh
Pediatrician
Makassed General Hospital