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Inhaled Furosemide for Transient Tachypnea of Newborn

Primary Purpose

Respiratory Morbidity

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Furosemide
Placebo
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Morbidity

Eligibility Criteria

1 Day - 1 Day (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Furosemide

Placebo

Arm Description

Patients will receive nebulised furosemide

Patients will receive nebulised 0.9% saline

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Length of hospital stay
Duration of hospital stay in days

Full Information

First Posted
May 18, 2020
Last Updated
August 28, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04397991
Brief Title
Inhaled Furosemide for Transient Tachypnea of Newborn
Official Title
Inhaled Furosemide for Transient Tachypnea of Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Morbidity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Experimental
Arm Description
Patients will receive nebulised furosemide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive nebulised 0.9% saline
Intervention Type
Other
Intervention Name(s)
Furosemide
Intervention Description
Patients will receive nebulised furosemide solution 1 mg/kg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive nebulised 0.9% saline
Primary Outcome Measure Information:
Title
Percentage of patients with respiratory morbidity
Description
Neonatal respiratory morbidity will be assessed through oxygen saturation, respiratory rate and duration on Continuous positive airway pressure (CPAP)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Duration of hospital stay in days
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Rajab, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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Inhaled Furosemide for Transient Tachypnea of Newborn

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