Inhaled Budesonide in Transient Tachypnea of the Newborn

  • STATUS
    Recruiting
  • days left to enroll
    59
  • participants needed
    50
  • sponsor
    Makassed General Hospital
Updated on 13 March 2021

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

Details
Condition respiratory distress
Treatment Placebo, Inhaled corticosteroids
Clinical Study IdentifierNCT04758078
SponsorMakassed General Hospital
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

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
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