Respiratory MorbidityNCT04397991
Inhaled Furosemide for Transient Tachypnea of Newborn
A study testing Furosemide in people with Respiratory Morbidity, run by Makassed General Hospital at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Respiratory Morbidity
- What is being tested?
- Furosemide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteLebanon
- Study dates
- 2 Jan 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%
Who cannot join
- Systemic infection
- Intubation and mechanical ventilation before Inclusion in the trail
- Malformation and any other disease with disturb of respiratory system
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Morbidity
- Being tested
- Furosemide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideOther
Patients will receive nebulised furosemide solution 1 mg/kg
PlaceboOther
Patients will receive nebulised 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | Patients will receive nebulised furosemide Receives: Other: Furosemide |
| Placebo | Placebo comparator | Patients will receive nebulised 0.9% saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (1)
Length of hospital stay
Duration of hospital stay in days
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start2 Jan 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rajab, Makassed General Hospital
- Investigators
- Mariam Rajab, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397991
- Sponsor's protocol ID
- 18122018
- Status last verified
- Aug 2022
- First submitted
- 18 May 2020
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Furosemide for Transient Tachypnea of Newborn
- ClinicalTrials.gov ID
- NCT04397991
- Acronym / sponsor ID
- 18122018
- Conditions
- Respiratory Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Other: FurosemidePatients will receive nebulised furosemide |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive nebulised 0.9% saline |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (3 listed)
- Systemic infection
- Intubation and mechanical ventilation before Inclusion in the trail
- Malformation and any other disease with disturb of respiratory system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemidePatients will receive nebulised furosemide solution 1 mg/kg | Other | Furosemide |
| PlaceboPatients will receive nebulised 0.9% saline | Other | Placebo |
Primary outcome
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)
1 secondary outcome
Length of hospital stay
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam Rajab, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide in people with Respiratory Morbidity, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with respiratory morbidity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.