Inhaled Budesonide in Transient Tachypnea of the Newborn

Respiratory Distress Clinical Trial

Official title:

Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758078
• Other study ID #: 09102020
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: August 2021

Study information

• Verified date: March 2021
• Source: Makassed General Hospital
• Contact: Sirin Mneimneh, MD
• Phone: +9611636000
• Email: sirin.mneimneh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress
• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Other:
• Inhaled corticosteroids
Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours
• Placebo
Nebulized 0.9% saline will be given four times per day

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of respiratory distress	Transient tachypnea of the newborn clinical score	within 48 hours
Secondary	Assessment of time to spontaneous breathing	Time to spontaneous unsupported breathing of room air (in hours)	with 48 hours