Respiratory DistressNCT04758078
Inhaled Budesonide in Transient Tachypnea of the Newborn
A study testing Inhaled corticosteroids in people with Respiratory Distress, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Respiratory Distress
- What is being tested?
- Inhaled corticosteroids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Feb 2021to 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 34 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 transient tachypnea of the newborn
- The need for Continuous positive airway pressure (CPAP) >6 hours to obtain the oxygen saturation >92%
Who cannot join
- Meconium aspiration syndrome;
- Respiratory distress syndrome
- Congenital heart Disease
- Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
- Pneumonia by chest x-ray
- Suspected sepsis/bacteremia
- Prenatal steroids
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut, +961
Sirin Mneimneh, MD, +9611636000 ext. 6317, sirin.mneimneh@hotmail.com
About this study
Official title: Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.
Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn
- Conditions
- Respiratory Distress
- Being tested
- Inhaled corticosteroids, Placebo
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled corticosteroidsOther
Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours
PlaceboOther
Nebulized 0.9% saline will be given four times per day
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids | Experimental | Patients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram) Receives: Other: Inhaled corticosteroids |
| Placebo | Placebo comparator | Patients will receive nebulized 0.9% saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of respiratory distress
Transient tachypnea of the newborn clinical score
Measured: within 48 hours
Secondary outcomes (1)
Assessment of time to spontaneous breathing
Time to spontaneous unsupported breathing of room air (in hours)
Measured: with 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Feb 2021
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sirin Mneimneh, Makassed General Hospital
- Investigators
- Sirin Mneimneh, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758078
- Sponsor's protocol ID
- 09102020
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2021
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04758078
- Acronym / sponsor ID
- 09102020
- Conditions
- Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 17 Feb 2021 (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.
Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.
Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn
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 |
|---|---|---|
| Corticosteroids | Experimental | Other: Inhaled corticosteroidsPatients will receive inhaled corticosteroids (Budesonide 2 mL = 1000 microgram) |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive nebulized 0.9% saline |
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
- Diagnosis of transient tachypnea of the newborn
- The need for Continuous positive airway pressure (CPAP) >6 hours to obtain the oxygen saturation >92%
Key exclusion criteria (7 listed)
- Meconium aspiration syndrome;
- Respiratory distress syndrome
- Congenital heart Disease
- Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
- Pneumonia by chest x-ray
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 |
|---|---|---|
| Inhaled corticosteroidsBudesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours | Other | Corticosteroids |
| PlaceboNebulized 0.9% saline will be given four times per day | Other | Placebo |
Primary outcome
Assessment of respiratory distress
Time frame: within 48 hours
Transient tachypnea of the newborn clinical score
1 secondary outcome
Assessment of time to spontaneous breathing
Time frame: with 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Sirin Mneimneh, 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 Inhaled corticosteroids in people with Respiratory Distress, 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 3 inclusion and 7 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 3 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirin Mneimneh, MD (+9611636000 ext. 6317, sirin.mneimneh@hotmail.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: within 48 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 3 Mar 2021.