Respiratory Distress
Conditions
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
Interventions
Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours
OTHERPlacebo
Nebulized 0.9% saline will be given four times per day
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
34 Weeks to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of respiratory distress | within 48 hours | Transient tachypnea of the newborn clinical score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of time to spontaneous breathing | with 48 hours | Time to spontaneous unsupported breathing of room air (in hours) |
Countries
Lebanon
Contacts
Primary ContactSirin Mneimneh, MD
Outcome results
None listed