NCT01858129

Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: All
• Age: 4 Hours – 6 Hours
• Healthy volunteers: Not accepted

Summary

Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid. The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.

Detailed description

The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.

Conditions

• Transient Tachypnea of the Newborn

Interventions

Type	Name	Description
DRUG	Experimental group: Budicort by Inhalation	Inhaled Budicort twice daily
DRUG	placebo

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-05-01
• First posted: 2013-05-21
• Last updated: 2015-01-29

Locations

1 site across 1 country: Israel