Inhaled Salbutamol in Elective Caesarean Section

Study Overview
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Brief Summary
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The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its activity, measured as nasal potential difference, correlates with lung compliance. Therefore, in the human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).

Detailed Description
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We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS). The aim of this study is to evaluate whether the respiratory status, measured by a transthoracic ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. 62 infants will be included and randomized to receive salbutamol or placebo-inhalations in a double-blind manner.

Official Title
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Inhaled Salbutamol in Elective Caesarean Section

Conditions
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Postnatal Pulmonary Adaptation, Cesarean Section

Intervention / Treatment
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* Drug: salbutamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy singleton pregnancy Cesarean section at 37 + 0 to 41 + 6 gestational weeks Exclusion Criteria: clinically significant congenital malformations birth weight < 2000 grams intubation 200 bp for more than 5 min relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids the suspicion of/confirmed pneumothorax or infection

Ages Eligible for Study
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Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo is administered once, at 30-60 minutes of age | Drug: Placebo<br>* Placebo given once as a dose of four puffs at 30-60 minutes of age<br>* Other names: Placebo, manufactured by GSK Finland;|
| Active Comparator: Intervention<br>Salbutamol 0,4 mg inhalation, given once at 30-60 minutes of age | Drug: salbutamol<br>* Medication given once as a dose of 4 puffs at 30-60 minutes of age<br>* Other names: Inhaled Ventoline (Evohaler) 0,1 mg/dos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth | To evaluate whether the respiratory status measured by a transthoracic ultrasound method of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age | To evaluate whether lung compliance of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. | 6 hours | 
| Decrease in respiratory rate at 3-6 hours of age | To see whether respiratory rate is decreased in infants receiving salbutamol at 30-60 minutes of age | 6 hours | 
| To see whether there is a correlation between airway ENaC expression measured at 30-60 minutes of age and consequent lung fluid content at 3-6 hours of age |  | 6 hours | 
| Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age | whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age | 6 hours of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung fluid, Postnatal adaptation, Salbutamol, Albuterol, Epithelial Sodium Channel