Inhaled Budesonide in Transient Tachypnea of the Newborn

Sponsor

Makassed General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04758078

Collaborator

(none)

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress	Other: Inhaled corticosteroids Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study

Actual Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Corticosteroids Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram)	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
Placebo Comparator: Placebo Patients will receive nebulized 0.9% saline	Other: Placebo Nebulized 0.9% saline will be given four times per day

Arm

Intervention/Treatment

Experimental: Corticosteroids

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

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

Placebo Comparator: Placebo

Patients will receive nebulized 0.9% saline

Other: Placebo

Nebulized 0.9% saline will be given four times per day

Outcome Measures

Primary Outcome Measures

Assessment of respiratory distress [within 48 hours]
Transient tachypnea of the newborn clinical score

Secondary Outcome Measures

Assessment of time to spontaneous breathing [with 48 hours]
Time to spontaneous unsupported breathing of room air (in hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:

34 Weeks and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makassed General Hospital	Beirut		Lebanon	+961

Sponsors and Collaborators

Makassed General Hospital

Investigators

Principal Investigator: Sirin Mneimneh, MD, Makassed General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Sirin Mneimneh, Pediatrician, Makassed General Hospital

ClinicalTrials.gov Identifier:

NCT04758078

Other Study ID Numbers:

09102020

First Posted:

Feb 17, 2021

Last Update Posted:

Mar 3, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tachypnea

Transient Tachypnea of the Newborn

Study Results

No Results Posted as of Mar 3, 2021