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.

NCT01858129 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Bnai Zion Medical Center
Phase	Phase 2
Status	UNKNOWN
Enrolment	56
Start date	2012-03

Conditions

• Transient Tachypnea of the Newborn

Interventions

• Experimental group: Budicort by Inhalation
• placebo

Primary outcomes

• Assessment of respiratory distress — 48 hours
  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 at 12, 24 and 48 hours after the first dose of inhaled study medication.

Countries

Israel