Transient Tachypnea of the NewbornPhase 2NCT01858129
Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
A Phase 2 study testing Experimental group: Budicort by Inhalation in people with Transient Tachypnea of the Newborn, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid. The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. Read more about this study
- Who is it for?
- Ages 4 to 6 hours
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- Experimental group: Budicort by Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to May 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 4 to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
- Diagnosis of TTN
- Parents signed informed consent
Who cannot join
- Meconium aspiration syndrome
- Respiratory distress syndrome
- Congenital heart disease
- Non respiratory disorders causing tachypnea
Trial locations and contacts
1 site in 1 country.
Amir Kugelman, MD contact
David Bader, MD contact
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Amir Kugelman, MD, 972-4-8359559, amirkug@gmail.com
David Bader, MD, 972-4-8359559, davidbade@gmail.com
About this study
Official title: Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.
The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.
Read the detailed description
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- Experimental group: Budicort by Inhalation, placebo
- Keywords
- TTN
- 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.
Experimental group: Budicort by InhalationDrug
Inhaled Budicort twice daily
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled steroids (Budicort) | Experimental | Inhaled Budicort Receives: Drug: Experimental group: Budicort by Inhalation |
| Control | Placebo comparator | Inhaled NS 0.9% Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of respiratory distress
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo at 12, 24 and 48 hours after the first dose of inhaled study medication.
Measured: 48 hours
Secondary outcomes (1)
The secondary outcome will be the assessment of morbidity associated with TTN
The secondary outcome will be the assessment of morbidity associated with TTN as reflected by time to spontaneous unsupported breathing of room air (hours), time to spontaneous breathing (LFNC and/or FiO2<0.3) for infants who got a higher level of respiratory support, maximal level of respiratory support (no oxygen, intra-incubator oxygen, LFNC, nCPAP, NIPPV, high flow nasal canulla, SIMV, HFOV), LOS (days), TFF (hours), need and length of antibiotic therapy in the study vs. placebo groups.
Measured: An average time period expected to be 5 days, according to the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMar 2012
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kugelman Amir, Bnai Zion Medical Center
- Investigators
- Amir Kugelman, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858129
- Sponsor's protocol ID
- 0090-11-BNZ
- Status last verified
- Jan 2015
- First submitted
- 14 May 2013
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaisbourd Y, Abu-Raya B, Zangen S, Arnon S, Riskin A, Shoris I, Elias N, Bader D, Kugelman A. Inhaled corticosteroids in transient tachypnea of the newborn: A randomized, placebo-controlled study. Pediatr Pulmonol. 2017 Aug;52(8):1043-1050. doi: 10.1002/ppul.23756. Epub 2017 Jul 3.
PubMed 28672098
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT01858129
- Acronym / sponsor ID
- 0090-11-BNZ
- Conditions
- Transient Tachypnea of the Newborn
- Keywords
- TTN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2012
- Primary completion
- May 2015 (estimated)
- First posted
- 21 May 2013 (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.
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.
The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.
Detailed description
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.
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 |
|---|---|---|
| Inhaled steroids (Budicort) | Experimental | Drug: Experimental group: Budicort by InhalationInhaled Budicort |
| Control | Placebo comparator | Drug: placeboInhaled NS 0.9% |
Who may qualify
- Ages
- 4 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
- Diagnosis of TTN
- Parents signed informed consent
Key exclusion criteria (4 listed)
- Meconium aspiration syndrome
- Respiratory distress syndrome
- Congenital heart disease
- Non respiratory disorders causing tachypnea
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 |
|---|---|---|
| Experimental group: Budicort by InhalationInhaled Budicort twice daily | Drug | Inhaled steroids (Budicort) |
| placebo | Drug | Control |
Primary outcome
Assessment of respiratory distress
Time frame: 48 hours
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo at 12, 24 and 48 hours after the first dose of inhaled study medication.
1 secondary outcome
The secondary outcome will be the assessment of morbidity associated with TTN
Time frame: An average time period expected to be 5 days, according to the duration of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Derived from this study: PubMed 28672098Vaisbourd Y, Abu-Raya B, Zangen S, Arnon S, Riskin A, Shoris I, Elias N, Bader D, Kugelman A. Inhaled corticosteroids in transient tachypnea of the newborn: A randomized, placebo-controlled study. Pediatr Pulmonol. 2017 Aug;52(8):1043-1050. doi: 10.1002/ppul.23756. Epub 2017 Jul 3.
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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.
Amir Kugelman, MD contact
David Bader, MD contact
Amir Kugelman, MD principal investigator
Bnai Zion Medical Center
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 Experimental group: Budicort by Inhalation in people with Transient Tachypnea of the Newborn, run by Bnai Zion Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 29 Jan 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 Israel. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Kugelman, MD (amirkug@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of respiratory distress (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01858129, which also lists 1 linked publication.
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 29 Jan 2015.