A Phase 2 interventional study of Experimental group: Budicort by Inhalation and placebo in Transient Tachypnea of the Newborn, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to participants aged 4 Hours to 6 Hours. Per ClinicalTrials.gov, last updated 2015-01-29.
Sponsored by Bnai Zion Medical Center · Phase 2, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Tachypnea; 4 are open to participants now.
This study's planned enrollment of 56 is below the median of 100 across 30 interventional studies indexed under Tachypnea.
Browse Tachypnea studies →Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Inhaled Budicort
Drug: Experimental group: Budicort by Inhalation
Inhaled NS 0.9%
Drug: placebo
Inhaled Budicort twice daily
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.
Time frame: 48 hours
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.
Time frame: An average time period expected to be 5 days, according to the duration of hospital stay
Will follow blood pressure
Blood pressure measurements
Time frame: An average time period expected to be 5 days, according to the duration of hospital stay
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Bnai Zion Medical Center