Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Transient Tachypnea of the Newborn

Intervention / Treatment
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* Drug: Experimental group: Budicort by Inhalation
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Hours
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled steroids (Budicort)<br>Inhaled Budicort | Drug: Experimental group: Budicort by Inhalation<br>* Inhaled Budicort twice daily<br>|
| Placebo Comparator: Control<br>Inhaled NS 0.9% | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | An average time period expected to be 5 days, according to the duration of hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTN