An interventional study of Salbutamol (Albuterol) and Normal Saline in TTN, sponsored by Latakia University. Not yet recruiting at 1 site in Syria. Open to participants aged 1 Hour to 6 Hours. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Latakia University · Not applicable, Interventional, and Treatment
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
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.
Latakia University is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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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.
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Exclusion Criteria:
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.)
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2 ml of 0.9% saline solution for inhalation
Drug: Normal Saline
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.
Drug: Salbutamol (Albuterol)
It belongs to a class of medications known as short-acting beta-2 adrenergic agonist.
normal saline by inhalation
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.
Time frame: 72 hours
Plan to share: Undecided
Start is estimated for Jan 2026; primary completion for Jan 2027, 12 months later.
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This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albuterol
Latakia University