Transient Tachypnea of the NewbornNCT01517958
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
An observational study of Transient Tachypnea of the Newborn and TTN, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress. Read more about this study
- Who is it for?
- Ages 28 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Transient Tachypnea of the Newborn, TTN, Respiratory Distress Syndrome
- What is being tested?
- Respiratory Distress Group
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2013
- Phase
- Observational
- 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 28 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.
Who may be able to join
- gestational age ≥ 28 weeks
- symptoms of respiratory distress defined as:
- tachypnea (respiratory rate > 60 breaths per minute)
- FiO2 requirement >21%
- intercostal/subcostal retractions
- grunting and/or nasal flaring
- If clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.
- Inclusion criteria for the control group will be gestational age ≥ 28 weeks with no symptoms of respiratory distress (defined above).
Who cannot join
- neonates with prenatally diagnosed structural cardiac disease
- major multiple congenital anomalies
- other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation
The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.
Read the detailed description
Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.
In preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.
Patients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population.
- Being tested
- Respiratory Distress Group, Control Group
- Keywords
- Transient tachypnea of the newborn, Respiratory Distress Syndrome, Lung Ultrasound, Neonates
- Medical subject headings
- Transient Tachypnea of the Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Distress GroupOther
Also called Diagnostic lung ultrasound.
Diagnostic lung ultrasound.
Control GroupOther
Lung ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Distress Group | Neonates 28 weeks GA or greater with respiratory distress Receives: Other: Respiratory Distress Group | |
| Control Group | Neonates 28 weeks GA or greater without respiratory distress. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound
The primary endpoint is to determine whether lung ultrasound is comparable or superior to chest radiography: (1) in making the diagnosis of RDS and TTN and (2) in differentiating between RDS and TTN.
Disease-specific lung ultrasound findings: (1) Double lung point in TTN and (2) lung white-out in RDS.
Measured: within first 24 hours of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Holzman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517958
- Sponsor's protocol ID
- GCO 11-0598
- Other IDs
- IF#1289354
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2012
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation
- ClinicalTrials.gov ID
- NCT01517958
- Acronym / sponsor ID
- GCO 11-0598
- Keywords
- Transient tachypnea of the newborn, Respiratory Distress Syndrome, Lung Ultrasound, Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Jan 2012 (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.
The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.
Detailed description
Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.
In preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.
Patients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Distress Group | – | Other: Respiratory Distress GroupNeonates 28 weeks GA or greater with respiratory distress |
| Control Group | – | Other: Control GroupNeonates 28 weeks GA or greater without respiratory distress. |
Who may qualify
- Ages
- 28 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.
Key inclusion criteria (8 listed)
- gestational age ≥ 28 weeks
- symptoms of respiratory distress defined as:
- tachypnea (respiratory rate > 60 breaths per minute)
- FiO2 requirement >21%
- intercostal/subcostal retractions
Key exclusion criteria (3 listed)
- neonates with prenatally diagnosed structural cardiac disease
- major multiple congenital anomalies
- other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).
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 |
|---|---|---|
| Respiratory Distress GroupAlso: Diagnostic lung ultrasound.Diagnostic lung ultrasound. | Other | Respiratory Distress Group |
| Control GroupLung ultrasound | Other | Control Group |
Primary outcome
lung ultrasound
Time frame: within first 24 hours of life.
The primary endpoint is to determine whether lung ultrasound is comparable or superior to chest radiography: (1) in making the diagnosis of RDS and TTN and (2) in differentiating between RDS and TTN. Disease-specific lung ultrasound findings: (1) Double lung point in TTN and (2) lung white-out in RDS.
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 25 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Transient Tachypnea of the Newborn
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Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
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Diastolic Dysfunction, Neonatal Encephalopathy
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Pulmonary Function Using Non-invasive Forced Oscillometry
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The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN
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the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
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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.
Ian Holzman, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Tachypnea of the Newborn and TTN, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 8 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 25 Mar 2016. 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 United States. 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.
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?
lung ultrasound (time frame: within first 24 hours of life.). 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 25 Mar 2016.