Inhaled Budesonide in Transient Tachypnea of the Newborn
Primary Purpose
Respiratory Distress
Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Inhaled corticosteroids
Placebo
Sponsored by

About this trial
This is an interventional other trial for Respiratory Distress
Eligibility Criteria
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
Sites / Locations
- Makassed General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Corticosteroids
Placebo
Arm Description
Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)
Patients will receive nebulized 0.9% saline
Outcomes
Primary Outcome Measures
Assessment of respiratory distress
Transient tachypnea of the newborn clinical score
Secondary Outcome Measures
Assessment of time to spontaneous breathing
Time to spontaneous unsupported breathing of room air (in hours)
Full Information
NCT ID
NCT04758078
First Posted
February 8, 2021
Last Updated
March 2, 2021
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04758078
Brief Title
Inhaled Budesonide in Transient Tachypnea of the Newborn
Official Title
Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroids
Arm Type
Experimental
Arm Description
Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive nebulized 0.9% saline
Intervention Type
Other
Intervention Name(s)
Inhaled corticosteroids
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Nebulized 0.9% saline will be given four times per day
Primary Outcome Measure Information:
Title
Assessment of respiratory distress
Description
Transient tachypnea of the newborn clinical score
Time Frame
within 48 hours
Secondary Outcome Measure Information:
Title
Assessment of time to spontaneous breathing
Description
Time to spontaneous unsupported breathing of room air (in hours)
Time Frame
with 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sirin Mneimneh, MD
Phone
+9611636000
Ext
6317
Email
sirin.mneimneh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirin Mneimneh, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
ZIP/Postal Code
+961
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sirin Mneimneh, MD
Phone
+9611636000
Ext
6317
Email
sirin.mneimneh@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Inhaled Budesonide in Transient Tachypnea of the Newborn
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