Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Phase 2

• Conditions: Transient Tachypnea of the Newborn
• Interventions: Drug: placebo

• Registration Number: NCT01858129
• Lead Sponsor: Bnai Zion Medical Center

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-21
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	placebo	Inhaled NS 0.9%

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	The secondary outcome will be the assessment of morbidity associated with TTN as reflected by time to spontaneous unsupported breathing of room air (hours), time to spontaneous breathing (LFNC and/or FiO2\<0.3) for infants who got a higher level of respiratory support, maximal level of respiratory support (no oxygen, intra-incubator oxygen, LFNC, nCPAP, NIPPV, high flow nasal canulla, SIMV, HFOV), LOS (days), TFF (hours), need and length of antibiotic therapy in the study vs. placebo groups.

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel