Inhaled Budesonide in Transient Tachypnea of the Newborn

NCT04758078 | Unknown

• 1 other identifier: 09102020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• Assessment of respiratory distress

  Transient tachypnea of the newborn clinical score

  within 48 hours

Secondary Outcomes (1)

• Assessment of time to spontaneous breathing

  with 48 hours

Study Arms (2)

Corticosteroids

EXPERIMENTAL

Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)

Other: Inhaled corticosteroids

Placebo

PLACEBO COMPARATOR

Patients will receive nebulized 0.9% saline

Other: Placebo

Interventions

Inhaled corticosteroids OTHER

Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours

Corticosteroids

Placebo OTHER

Nebulized 0.9% saline will be given four times per day

Placebo

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, +961, Lebanon

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sirin Mneimneh, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirin Mneimneh, MD

CONTACT

+9611636000; sirin.mneimneh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: February 15, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

LE (1)