Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01858129

Enrollment

Registered

2013-05-21

Start date

2012-03-31

Completion date

Unknown

Last updated

2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Tachypnea of the Newborn

Keywords

TTN

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.

Detailed 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.

Interventions

DRUGExperimental group: Budicort by Inhalation

Inhaled Budicort twice daily

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Hours to 6 Hours

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of respiratory distress	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.

Secondary

Measure	Time frame	Description
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	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.

Other

Measure	Time frame	Description
Will follow blood pressure	An average time period expected to be 5 days, according to the duration of hospital stay	Blood pressure measurements

Countries

Israel

Contacts

Primary ContactAmir Kugelman, MD

amirkug@gmail.com

Backup ContactDavid Bader, MD

davidbade@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026