Inhaled Salbutamol in Elective Caesarean Section

Cesarean Section Clinical Trial

— SAISTY  

Official title:

Inhaled Salbutamol in Elective Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01978418
• Other study ID #: SAISTY-1
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: December 5, 2014
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Helsinki University Central Hospital
• Contact: Cecilia Janér, MD
• Phone: +35894711
• Email: cecilia.janer[@]helsinki.fi
• Is FDA regulated: No
• Health authority: Fimea: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Hour

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section
• Postnatal Pulmonary Adaptation

Intervention

Drug:
• salbutamol
Medication given once as a dose of 4 puffs at 30-60 minutes of age
• Placebo
Placebo given once as a dose of four puffs at 30-60 minutes of age

Locations

Country	Name	City	State
Finland	Women's Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Sture Andersson

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No