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CompletedNCT04397991Updated Aug 30, 2022

Inhaled Furosemide for Transient Tachypnea of Newborn

An interventional study of Furosemide and Placebo in Respiratory Morbidity, sponsored by Makassed General Hospital. Completed at 1 site in Lebanon. Open to participants aged 1 Day to 1 Day. Per ClinicalTrials.gov, last updated 2022-08-30.

Sponsored by Makassed General Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2020, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
1 Day to 1 Day
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Morbidity
03

In context

Lead sponsor

Makassed General Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Day
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Systemic infection
  • Intubation and mechanical ventilation before Inclusion in the trail
  • Malformation and any other disease with disturb of respiratory system
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Furosemide

    Patients will receive nebulised furosemide

    Other: Furosemide

  • Placebo comparator
    Placebo

    Patients will receive nebulised 0.9% saline

    Other: Placebo

Interventions

  • OtherFurosemide

    Patients will receive nebulised furosemide solution 1 mg/kg

  • OtherPlacebo

    Patients will receive nebulised 0.9% saline

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 hours

Secondary outcomes

  1. Length of hospital stay

    Duration of hospital stay in days

    Time frame: 15 days

07

Study locations

1 site
  • Makassed General Hospital
    Beirut, Lebanon
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Aug 2021, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2020
First posted
May 21, 2020
StartActual
Jan 2, 2020
Primary completionActual
Aug 1, 2021
CompletionActual
Aug 1, 2021
Last update
Aug 30, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04397991
Lead sponsor
Makassed General Hospital
Responsible party
Mariam Rajab (Principal Investigator, Makassed General Hospital) — Principal investigator
First posted
May 21, 2020
Start date
Jan 2, 2020
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Last update
Aug 30, 2022

Study contacts

Mariam Rajab, MD
principal investigator · Makassed General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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