Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Transient Tachypnea of the Newborn Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01858129
• Other study ID #: 0090-11-BNZ
• Status: Recruiting
• Phase: Phase 2
• First received: May 14, 2013
• Last updated: January 28, 2015
• Start date: March 2012

Study information

• Verified date: January 2015
• Source: Bnai Zion Medical Center
• Contact: Amir Kugelman, MD
• Email: amirkug[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Drug:
• Experimental group: Budicort by Inhalation
Inhaled Budicort twice daily
• placebo

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Will follow blood pressure	Blood pressure measurements	An average time period expected to be 5 days, according to the duration of hospital stay	Yes
Primary	Assessment of respiratory distress	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.	48 hours	No
Secondary	The secondary outcome will be the assessment of morbidity associated with TTN	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.	An average time period expected to be 5 days, according to the duration of hospital stay	No