The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Salbutamol (Albuterol), Normal Saline.
- Who it may be relevant to
- Registry conditions: TTN. Basic parameters: 1 Hour — 6 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Syria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Salbutamol (Albuterol)
It belongs to a class of medications known as short-acting beta-2 adrenergic agonist. - Drug Normal Saline
normal saline by inhalation
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Syria · 1 center
- Latakia University — Latakia
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. PMID 24587948
Identifiers
NCT: NCT07350421 · TTN , newborn