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Inhaled Budesonide in Transient Tachypnea of the Newborn

NCT04758078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Principal Investigators

  • Sirin Mneimneh, MD · Makassed General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758078 on ClinicalTrials.gov