Inhaled Budesonide in Transient Tachypnea of the Newborn

Not Applicable

• Conditions: Respiratory Distress
• Interventions: Other: Placebo; Other: Inhaled corticosteroids

• Registration Number: NCT04758078
• Lead Sponsor: Makassed General Hospital

Brief Summary

Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.

Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-12
• Study Start: 2021-02-15
• Study First Posted: 2021-02-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
• Diagnosis of transient tachypnea of the newborn
• The need for Continuous positive airway pressure (CPAP) >6 hours to obtain the oxygen saturation >92%

Exclusion Criteria

• Meconium aspiration syndrome;
• Respiratory distress syndrome
• Congenital heart Disease
• Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
• Pneumonia by chest x-ray
• Suspected sepsis/bacteremia
• Prenatal steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive nebulized 0.9% saline
Corticosteroids	Inhaled corticosteroids	Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)

Primary Outcome Measures

Name	Time	Method
Assessment of respiratory distress	within 48 hours	Transient tachypnea of the newborn clinical score

Secondary Outcome Measures

Name	Time	Method
Assessment of time to spontaneous breathing	with 48 hours	Time to spontaneous unsupported breathing of room air (in hours)

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon