Clinical trial NCT01978418: Inhaled Salbutamol in Elective Caesarean Section
Official title: Inhaled Salbutamol in Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postnatal Pulmonary Adaptation
Cesarean Section
Keywords: Lung fluid
Postnatal adaptation
Salbutamol
Albuterol
Epithelial Sodium Channel
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 62
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth
timeFrame: 6 hours
Secondary outcomes:
measure: To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age
timeFrame: 6 hours
measure: Decrease in respiratory rate at 3-6 hours of age
timeFrame: 6 hours
measure: 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
timeFrame: 6 hours
measure: Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age
timeFrame: 6 hours of age
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Women's Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Sture Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: