Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
NCT ID: NCT01858129
Last Updated: 2015-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
56 participants
INTERVENTIONAL
2012-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaled steroids (Budicort)
Inhaled Budicort
Experimental group: Budicort by Inhalation
Inhaled Budicort twice daily
Control
Inhaled NS 0.9%
placebo
Interventions
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Experimental group: Budicort by Inhalation
Inhaled Budicort twice daily
placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of TTN
* Parents signed informed consent
Exclusion Criteria
* Respiratory distress syndrome
* Congenital heart disease
* Non respiratory disorders causing tachypnea
4 Hours
6 Hours
ALL
No
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Kugelman Amir
Head, Pediatric Pulmonary Unit
Principal Investigators
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Amir Kugelman, MD
Role: PRINCIPAL_INVESTIGATOR
Bnai Zion Medical Center
Locations
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Bnai Zion Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Vaisbourd Y, Abu-Raya B, Zangen S, Arnon S, Riskin A, Shoris I, Elias N, Bader D, Kugelman A. Inhaled corticosteroids in transient tachypnea of the newborn: A randomized, placebo-controlled study. Pediatr Pulmonol. 2017 Aug;52(8):1043-1050. doi: 10.1002/ppul.23756. Epub 2017 Jul 3.
Other Identifiers
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0090-11-BNZ
Identifier Type: -
Identifier Source: org_study_id
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