Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 14, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedJanuary 29, 2015
January 1, 2015
3.2 years
May 14, 2013
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Other Outcomes (1)
Will follow blood pressure
An average time period expected to be 5 days, according to the duration of hospital stay
Study Arms (2)
Inhaled steroids (Budicort)
EXPERIMENTALInhaled Budicort
Control
PLACEBO COMPARATORInhaled NS 0.9%
Interventions
Inhaled Budicort twice daily
Eligibility Criteria
You may qualify if:
- Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
- Diagnosis of TTN
- Parents signed informed consent
You may not qualify if:
- Meconium aspiration syndrome
- Respiratory distress syndrome
- Congenital heart disease
- Non respiratory disorders causing tachypnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bnai Zion Medical Center
Haifa, Israel
Related Publications (1)
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.
PMID: 28672098DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Kugelman, MD
Bnai Zion Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Pediatric Pulmonary Unit
Study Record Dates
First Submitted
May 14, 2013
First Posted
May 21, 2013
Study Start
March 1, 2012
Primary Completion
May 1, 2015
Last Updated
January 29, 2015
Record last verified: 2015-01