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NCT04397991 Clinical Trial

Inhaled Furosemide for Transient Tachypnea of Newborn

Respiratory Morbidity Clinical Trial

Official title:
Inhaled Furosemide for Transient Tachypnea of Newborn

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04397991
Other study ID # 18122018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date August 1, 2021

Study information
Verified date August 2022
Source Makassed General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized double blind clinical trial in which newborns with suspected Transient tachypnea of the newborn (TTN) will receive either furosemide or normal saline by nebulizer every 6 hours for 24 hours.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Day to 1 Day
Eligibility Inclusion Criteria: - Neonates with 34+0-39+0 gestational age - on the first day of life - with the clinical diagnosis of Transient Tachypnoea - need for CPAP >6 hours to obtain the oxygen saturation >92% Exclusion Criteria: - Systemic infection - Intubation and mechanical ventilation before Inclusion in the trail - Malformation and any other disease with disturb of respiratory system

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Furosemide
Patients will receive nebulised furosemide solution 1 mg/kg
• Placebo
Patients will receive nebulised 0.9% saline

Locations
Country Name City State
Lebanon Makassed General Hospital Beirut

Sponsors (1)
Lead Sponsor Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with respiratory morbidity Neonatal respiratory morbidity will be assessed through oxygen saturation, respiratory rate and duration on Continuous positive airway pressure (CPAP) 24 hours
Secondary Length of hospital stay Duration of hospital stay in days 15 days
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