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.
Overview
- Phase
- Phase 2
- Intervention
- placebo
- Conditions
- Transient Tachypnea of the Newborn
- Sponsor
- Bnai Zion Medical Center
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Assessment of respiratory distress
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Kugelman Amir
Head, Pediatric Pulmonary Unit
Bnai Zion Medical Center
Eligibility Criteria
Inclusion Criteria
- •Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
- •Diagnosis of TTN
- •Parents signed informed consent
Exclusion Criteria
- •Meconium aspiration syndrome
- •Respiratory distress syndrome
- •Congenital heart disease
- •Non respiratory disorders causing tachypnea
Arms & Interventions
Control
Inhaled NS 0.9%
Intervention: placebo
Outcomes
Primary Outcomes
Assessment of respiratory distress
Time Frame: 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.
Secondary Outcomes
- The secondary outcome will be the assessment of morbidity associated with TTN(An average time period expected to be 5 days, according to the duration of hospital stay)