Inhaled Furosemide for Transient Tachypnea of Newborn

NCT ID: NCT04397991

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Furosemide

Patients will receive nebulised furosemide

Group Type EXPERIMENTAL

Furosemide

Intervention Type OTHER

Patients will receive nebulised furosemide solution 1 mg/kg

Placebo

Patients will receive nebulised 0.9% saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive nebulised 0.9% saline

Interventions

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Furosemide

Patients will receive nebulised furosemide solution 1 mg/kg

Intervention Type OTHER

Placebo

Patients will receive nebulised 0.9% saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mariam Rajab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariam Rajab, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

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Makassed General Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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18122018

Identifier Type: -

Identifier Source: org_study_id

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