NCT01978418

Inhaled Salbutamol in Elective Caesarean Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sture Andersson · Academic / Other
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Accepted

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.

Conditions

• Postnatal Pulmonary Adaptation
• Cesarean Section

Interventions

Type	Name	Description
DRUG	salbutamol	Medication given once as a dose of 4 puffs at 30-60 minutes of age
DRUG	Placebo	Placebo given once as a dose of four puffs at 30-60 minutes of age

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2013-11-07
• Last updated: 2014-12-08

Locations

1 site across 1 country: Finland