search
Back to results

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
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Distress

Eligibility Criteria

34 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 8, 2021
Last Updated
March 2, 2021
Sponsor
Makassed General Hospital
search

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

We'll reach out to this number within 24 hrs