Transient Tachypnoea of the NewbornPhase 2NCT01407848
Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
A Phase 2 study testing Furosemide and Saline 0,9% in people with Transient Tachypnoea of the Newborn, run by University of Cologne at 1 site in Germany.
Trial summary
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea. Read more about this study
- Who is it for?
- Ages 6 hours and older
- Conditions the study is for
- Transient Tachypnoea of the Newborn
- What is being tested?
- Furosemide and Saline 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jul 2015
- Phase
- Phase 2
- 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 6 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
- The need for CPAP >6 h to obtain the oxygen saturation >92%
- Written informed consent of parent/guardian
Who cannot join
- Systemic infection
- Intubation and mechanical ventilation before Inclusion in the trail
- Malformation and any other several disease with disturb of respiratory
- Subjects participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site
Children´s Hospital University of Cologne
Cologne, North Rhine-Westphalia, 50931
About this study
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.
Read the detailed description
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient Tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order so long as need a CPAP-treatment but max. 3 days. 20 Patient will be treating.
The benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on CPAP.
- Conditions
- Transient Tachypnoea of the Newborn
- Being tested
- Furosemide, Saline 0,9%
- 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.
FurosemideDrug
Also called inhaled furosemide
Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
Saline 0,9%Drug
Also called natrium chloride
nebulised 0,9% saline 4x/d for max.3 days
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | 1 mg/kg/Ed Receives: Drug: Furosemide |
| Saline 0,9% | Active comparator | 1ml/kg/Ed Receives: Drug: Saline 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the Silverman-Score
The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant.
Silverman Score is the standard score to describe the degree of respiratory distress of neonate.
Measured: 0-72 h or up to end of CPAP after start of the study
Secondary outcomes (6)
Oxygen supplementation
Measured: 0-72 h or up to end of CPAP after start of the study
A need for secondary intubation and mechanical ventilation
Measured: 1-3 day of life
body weight
Measured: 1-3 day of life
CPAP-time
Measured: 0-72 h or up to end of CPAP after start of the study
blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)
Measured: 0-72 h after start of the study
blood gas (pH, pCO2,pO2)
Measured: 0-72 h after start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnoea 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrizia Nitsch-Felsecker, University of Cologne
- Investigators
- Bernhard Roth, Prof. Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407848
- Sponsor's protocol ID
- Uni-Koeln-1488
- Other IDs
- 2011-003473-29
- Status last verified
- Sep 2015
- First submitted
- 28 Jul 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
- ClinicalTrials.gov ID
- NCT01407848
- Acronym / sponsor ID
- Uni-Koeln-1488
- Conditions
- Transient Tachypnoea of the Newborn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Aug 2011 (estimated)
- 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.
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.
Detailed description
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient Tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order so long as need a CPAP-treatment but max. 3 days. 20 Patient will be treating.
The benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: Furosemide1 mg/kg/Ed |
| Saline 0,9% | Active comparator | Drug: Saline 0,9%1ml/kg/Ed |
Who may qualify
- Ages
- 6 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
- The need for CPAP >6 h to obtain the oxygen saturation >92%
- Written informed consent of parent/guardian
Key exclusion criteria (4 listed)
- Systemic infection
- Intubation and mechanical ventilation before Inclusion in the trail
- Malformation and any other several disease with disturb of respiratory
- Subjects participating in other clinical trials
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 |
|---|---|---|
| FurosemideAlso: inhaled furosemidePatients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days. | Drug | Furosemide |
| Saline 0,9%Also: natrium chloridenebulised 0,9% saline 4x/d for max.3 days | Drug | Saline 0,9% |
Primary outcome
Reduction of the Silverman-Score
Time frame: 0-72 h or up to end of CPAP after start of the study
The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant. Silverman Score is the standard score to describe the degree of respiratory distress of neonate.
6 secondary outcomes
Oxygen supplementation
Time frame: 0-72 h or up to end of CPAP after start of the study
A need for secondary intubation and mechanical ventilation
Time frame: 1-3 day of life
body weight
Time frame: 1-3 day of life
CPAP-time
Time frame: 0-72 h or up to end of CPAP after start of the study
blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)
Time frame: 0-72 h after start of the study
blood gas (pH, pCO2,pO2)
Time frame: 0-72 h after start of the study
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 23 Sep 2015.
Related trials for Transient Tachypnoea of the Newborn
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Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruitingObservational study
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Diastolic Dysfunction, Neonatal Encephalopathy
Active, not recruiting
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.
Bernhard Roth, Prof. Dr. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furosemide and Saline 0,9% in people with Transient Tachypnoea of the Newborn, run by University of Cologne at 1 site in Germany.
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 3 inclusion and 4 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 23 Sep 2015. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction of the Silverman-Score (time frame: 0-72 h or up to end of CPAP after start of the study). 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 23 Sep 2015.