Transient Tachypnea of the NewbornPhase 3NCT03208894
Role of Salbutamol and Furosemide in TTN
A Phase 3 study testing Furosemide Injection in people with Transient Tachypnea of the Newborn, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.
Trial summary
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn Read more about this study
- Who is it for?
- Ages 1 hour to 7 days
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- Furosemide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Nov 2016to 30 Jun 2017
- Phase
- Phase 3
- 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 hour to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all newborn babies with clinically diagnosed TTN
Who cannot join
- babies less than 34 weeks babies with congenital malformations and CHD
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Department of Pediatrics
Rawalpindi, Punjab Province, 68000
Military Hospital
Rawalpindi, Punjab Province, 68000
About this study
Official title: Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- Furosemide Injection
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide InjectionDrug
Also called salbutamol inhalation
efficacy of salbutamol and furosemide in TTN
| Study group | Role | What they receive |
|---|---|---|
| with salbutamol | Experimental | Not described Receives: Drug: Furosemide Injection |
| with furosemide | Experimental | Not described Receives: Drug: Furosemide Injection |
| both furosemide and salbutamol | Experimental | Not described Receives: Drug: Furosemide Injection |
| no inervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of oxygen requiremment in neonates having TTN.
neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.
Measured: upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Nov 2016
- Primary completion30 May 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea of the NewbornStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arshad khushdil, Armed Forces Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208894
- Sponsor's protocol ID
- TTN
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn
- ClinicalTrials.gov ID
- NCT03208894
- Acronym / sponsor ID
- TTN
- Conditions
- Transient Tachypnea of the Newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Jul 2017 (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.
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| with salbutamol | Experimental | Drug: Furosemide Injection |
| with furosemide | Experimental | Drug: Furosemide Injection |
| both furosemide and salbutamol | Experimental | Drug: Furosemide Injection |
| no inervention | No intervention | – |
Who may qualify
- Ages
- 1 hour to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all newborn babies with clinically diagnosed TTN
Key exclusion criteria (1 listed)
- babies less than 34 weeks babies with congenital malformations and CHD
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 |
|---|---|---|
| Furosemide InjectionAlso: salbutamol inhalationefficacy of salbutamol and furosemide in TTN | Drug | both furosemide and salbutamol, with furosemide, with salbutamol |
Primary outcome
duration of oxygen requiremment in neonates having TTN.
Time frame: upto 6 months
neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.
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 6 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Transient Tachypnea of the Newborn
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Active, not recruitingObservational study
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Diastolic Dysfunction, Neonatal Encephalopathy
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Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
Not yet recruiting
The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN
Active, not recruitingPhase 3
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
TTN, Respiratory Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide Injection in people with Transient Tachypnea of the Newborn, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.
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 1 inclusion and 1 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of oxygen requiremment in neonates having TTN. (time frame: upto 6 months). 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 6 Jul 2017.