Inhaled Budesonide in Transient Tachypnea of the Newborn

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2021

Interventions

  • 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
  • Other: Placebo
    • Nebulized 0.9% saline will be given four times per day

Arms, Groups and Cohorts

  • Experimental: Corticosteroids
    • Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)
  • Placebo Comparator: Placebo
    • Patients will receive nebulized 0.9% saline

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of respiratory distress
    • Time Frame: within 48 hours
    • Transient tachypnea of the newborn clinical score

Secondary Measures

  • Assessment of time to spontaneous breathing
    • Time Frame: with 48 hours
    • Time to spontaneous unsupported breathing of room air (in hours)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 34 Weeks

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Makassed General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Sirin Mneimneh, Pediatrician – Makassed General Hospital
  • Overall Official(s)
    • Sirin Mneimneh, MD, Principal Investigator, Makassed General Hospital
  • Overall Contact(s)
    • Sirin Mneimneh, MD, +9611636000, sirin.mneimneh@hotmail.com

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