Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Bnai Zion Medical Center

Status and phase: Unknown; Phase 2

Conditions: Transient Tachypnea of the Newborn

Treatments: Drug: placebo; Drug: Experimental group: Budicort by Inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT01858129

0090-11-BNZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 4 to 6 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Inhaled steroids (Budicort)

Experimental group

Description:

Inhaled Budicort

Treatment:

Drug: Experimental group: Budicort by Inhalation

Control

Placebo Comparator group

Description:

Inhaled NS 0.9%

Treatment:

Drug: placebo