Inhaled Budesonide in Transient Tachypnea of the Newborn

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

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress
• Intervention / Treatment: Other: Inhaled corticosteroids; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sirin Mneimneh, MD; Phone Number: 6317 +9611636000; Email: sirin.mneimneh@hotmail.com

Study Locations

• Lebanon
  • Beirut, Lebanon, +961
    • Recruiting
    • Makassed General Hospital
    • Contact: Sirin Mneimneh, MD; Phone Number: 6317 +9611636000; Email: sirin.mneimneh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Corticosteroids; Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)	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_COMPARATOR: Placebo; Patients will receive nebulized 0.9% saline	Other: Placebo; Nebulized 0.9% saline will be given four times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of respiratory distress	Transient tachypnea of the newborn clinical score	within 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of time to spontaneous breathing	Time to spontaneous unsupported breathing of room air (in hours)	with 48 hours

Collaborators and Investigators

• Sponsor: Makassed General Hospital
• Investigators: Principal Investigator: Sirin Mneimneh, MD, Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2021
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: 09102020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No