Inhaled Budesonide in Transient Tachypnea of the Newborn

Makassed General Hospital

Status: Unknown

Conditions: Respiratory Distress

Treatments: Other: Placebo; Other: Inhaled corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT04758078

09102020

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 34+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Corticosteroids

Experimental group

Description:

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

Treatment:

Other: Inhaled corticosteroids

Placebo

Placebo Comparator group

Description:

Patients will receive nebulized 0.9% saline

Treatment:

Other: Placebo