Inhaled Budesonide in Transient Tachypnea of the Newborn

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Respiratory Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Corticosteroids

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

Group Type EXPERIMENTAL

Inhaled corticosteroids

Intervention Type OTHER

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

Placebo

Patients will receive nebulized 0.9% saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Nebulized 0.9% saline will be given four times per day

Interventions

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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

Intervention Type OTHER

Placebo

Nebulized 0.9% saline will be given four times per day

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No