Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
|ClinicalTrials.gov Identifier: NCT01858129|
Recruitment Status : Unknown
Verified January 2015 by Kugelman Amir, Bnai Zion Medical Center.
Recruitment status was: Recruiting
First Posted : May 21, 2013
Last Update Posted : January 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Transient Tachypnea of the Newborn||Drug: Experimental group: Budicort by Inhalation Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||May 2015|
Experimental: Inhaled steroids (Budicort)
Drug: Experimental group: Budicort by Inhalation
Inhaled Budicort twice daily
Placebo Comparator: Control
Inhaled NS 0.9%
- 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.
- The secondary outcome will be the assessment of morbidity associated with TTN [ Time Frame: 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.
- Will follow blood pressure [ Time Frame: An average time period expected to be 5 days, according to the duration of hospital stay ]Blood pressure measurements
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858129
|Bnai Zion Medical Center||Recruiting|
|Contact: Amir Kugelman, MD 972-4-8359559 email@example.com|
|Contact: David Bader, MD 972-4-8359559 firstname.lastname@example.org|
|Sub-Investigator: David Bader, MD|
|Principal Investigator:||Amir Kugelman, MD||Bnai Zion Medical Center|