Inhaled Furosemide for Transient Tachypnea of Newborn

August 28, 2022 updated by: Mariam Rajab, Makassed General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Makassed General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furosemide
Patients will receive nebulised furosemide
Other: Furosemide
Patients will receive nebulised furosemide solution 1 mg/kg
Placebo Comparator: Placebo
Patients will receive nebulised 0.9% saline
Other: Placebo
Patients will receive nebulised 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with respiratory morbidity
Time Frame: 24 hours
Neonatal respiratory morbidity will be assessed through oxygen saturation, respiratory rate and duration on Continuous positive airway pressure (CPAP)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 15 days
Duration of hospital stay in days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makassed General Hospital

Investigators

  • Principal Investigator: Mariam Rajab, MD, Makassed General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18122018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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