TTNNCT07350421
The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
A study testing Salbutamol (Albuterol) and Normal Saline in people with TTN, run by Latakia University at 1 site in Syria.
Trial summary
TTN is the most common respiratory disorder in the perinatal period, causing 40% of cases of respiratory distress after birth. Lung fluid absorption is initiated by beta-adrenergic agonists, such as endogenous steroids and Catecholamine, which increase during labor. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- TTN
- What is being tested?
- Salbutamol (Albuterol) and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth at the study hospital at a gestational age greater than 35 weeks. Clinical signs of TTN (tachypnea, retractions, grunting, nasal flaring) within the first 6 hours after birth.
- -
Who cannot join
- gestational age is 35 weeks or less. Meconium aspiration syndrome Pulmonary hypertension Congenital pneumonia and sepsis Congenital cardiovascular malformations Congenital thoracic and pulmonary malformations (diaphragmatic hernia, pulmonary hypoplasia, etc.)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site
Latakia University
Latakia, Latakia Governorate
Nabih Raslan, Dr, +963999140762, president@tishreen.edu.sy
About this study
TTN is the most common respiratory disorder in the perinatal period, causing 40% of cases of respiratory distress after birth. Lung fluid absorption is initiated by beta-adrenergic agonists, such as endogenous steroids and Catecholamine, which increase during labor. Delayed absorption of fluid from the lungs is thought to be the primary mechanism of transient tachypnea of the newborn (TTN). The accumulation of fluid within the lungs impairs gas exchange, leading to increased respiratory effort. Tachypnea develops to compensate for this, and hypoxemia develops due to impaired alveolar ventilation . The main objective of the study:
To study the effectiveness of salbutamol in improving signs of respiratory distress according to the modified Downes score during the first 72 hours of life in infants with transient tachypnea of the newborn (TTN). Secondary objectives:
Duration of tachypnea (time to resolution of respiratory distress) Reducing the duration of the need for oxygen support Reducing the length of hospital stay
Read the detailed description
Patients will be divided into two groups:
Intervention group B: receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.
Control group A: receives 2 ml of 0.9% normal saline. The study population consists of newborns born at Al-Ladhiqiyah University Hospital with a gestational age greater than 35 weeks who show signs of respiratory distress within the first 6 hours of birth.
- Conditions
- TTN
- Being tested
- Salbutamol (Albuterol), Normal Saline
- Keywords
- TTN, newboen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol (Albuterol)Drug
It belongs to a class of medications known as short-acting beta-2 adrenergic agonist.
Normal SalineDrug
normal saline by inhalation
| Study group | Role | What they receive |
|---|---|---|
| A control group | Placebo comparator | 2 ml of 0.9% saline solution for inhalation Receives: Drug: Normal Saline |
| B intervention group | Active comparator | The patient receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline. Receives: Drug: Salbutamol (Albuterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
study on the effectiveness of salbutamol in improving respiratory distress signs according to the modified Downes score during the first 72 hours of life in infants with TTN.
Respiratory distress scores will be assessed using the modified Downes score ten minutes before the specified intervention is applied, and again at 6, 12, 24, 48, and 72 hours after the intervention begins.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2028 (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 TTNStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnan Dayoub, PHD, Study chair, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350421
- Sponsor's protocol ID
- TTN , newborn
- Status last verified
- Oct 2025
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim MJ, Yoo JH, Jung JA, Byun SY. The effects of inhaled albuterol in transient tachypnea of the newborn. Allergy Asthma Immunol Res. 2014 Mar;6(2):126-30. doi: 10.4168/aair.2014.6.2.126. Epub 2013 Nov 15.
PubMed 24587948
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
- ClinicalTrials.gov ID
- NCT07350421
- Acronym / sponsor ID
- TTN , newborn
- Conditions
- TTN
- Keywords
- TTN, newboen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
TTN is the most common respiratory disorder in the perinatal period, causing 40% of cases of respiratory distress after birth. Lung fluid absorption is initiated by beta-adrenergic agonists, such as endogenous steroids and Catecholamine, which increase during labor. Delayed absorption of fluid from the lungs is thought to be the primary mechanism of transient tachypnea of the newborn (TTN). The accumulation of fluid within the lungs impairs gas exchange, leading to increased respiratory effort. Tachypnea develops to compensate for this, and hypoxemia develops due to impaired alveolar ventilation . The main objective of the study:
To study the effectiveness of salbutamol in improving signs of respiratory distress according to the modified Downes score during the first 72 hours of life in infants with transient tachypnea of the newborn (TTN). Secondary objectives:
Duration of tachypnea (time to resolution of respiratory distress) Reducing the duration of the need for oxygen support Reducing the length of hospital stay
Detailed description
Patients will be divided into two groups:
Intervention group B: receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.
Control group A: receives 2 ml of 0.9% normal saline. The study population consists of newborns born at Al-Ladhiqiyah University Hospital with a gestational age greater than 35 weeks who show signs of respiratory distress within the first 6 hours of birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The patient receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline.
| Arm | Type | Receives |
|---|---|---|
| A control group | Placebo comparator | Drug: Normal Saline2 ml of 0.9% saline solution for inhalation |
| B intervention group | Active comparator | Drug: Salbutamol (Albuterol)The patient receives a single dose of inhaled salbutamol at a dose of 0.15 mg/kg mixed with 2 ml of 0.9% normal saline. |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth at the study hospital at a gestational age greater than 35 weeks. Clinical signs of TTN (tachypnea, retractions, grunting, nasal flaring) within the first 6 hours after birth.
- -
Key exclusion criteria (2 listed)
- gestational age is 35 weeks or less. Meconium aspiration syndrome Pulmonary hypertension Congenital pneumonia and sepsis Congenital cardiovascular malformations Congenital thoracic and pulmonary malformations (diaphragmatic hernia, pulmonary hypoplasia, etc.)
- -
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 |
|---|---|---|
| Salbutamol (Albuterol)It belongs to a class of medications known as short-acting beta-2 adrenergic agonist. | Drug | B intervention group |
| Normal Salinenormal saline by inhalation | Drug | A control group |
Primary outcome
study on the effectiveness of salbutamol in improving respiratory distress signs according to the modified Downes score during the first 72 hours of life in infants with TTN.
Time frame: 72 hours
Respiratory distress scores will be assessed using the modified Downes score ten minutes before the specified intervention is applied, and again at 6, 12, 24, 48, and 72 hours after the intervention begins.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 24587948Kim MJ, Yoo JH, Jung JA, Byun SY. The effects of inhaled albuterol in transient tachypnea of the newborn. Allergy Asthma Immunol Res. 2014 Mar;6(2):126-30. doi: 10.4168/aair.2014.6.2.126. Epub 2013 Nov 15.
- Effects of Salbutamol on the Treatment of Transient Tachypnea of the NewbornLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for TTN
Recruiting
Urinary Titin Biomarker in DMD
Duchenne Muscular Dystrophy (DMD), Becker's Muscular Dystrophy (BMD)
Active, not recruitingPhase 3
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
TTN, Respiratory Failure
RecruitingObservational study
Congenital Muscle Disease Study of Patient and Family Reported Medical Information
Congenital Muscular Dystrophy With ITGA7 (Integrin Alpha-7) Deficiency, Alpha-Dystroglycanopathy (Congenital Muscular Dystrophy and Abnormal Glycosylation of Dystroglycan With Severe Epilepsy)
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.
Adnan Dayoub, PHD study chair
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol (Albuterol) and Normal Saline in people with TTN, run by Latakia University at 1 site in Syria.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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 Syria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jawad thaer shhada, D.r (+963991861748, jawad.th.shahada@latakia-univ.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study on the effectiveness of salbutamol in improving respiratory distress signs according to the modified Downes score during the first 72 hours of life in infants with TTN. (time frame: 72 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 NCT07350421, 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 20 Jan 2026.