Inhaled Salbutamol in Elective Caesarean Section (SAISTY)

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).

Study Overview

• Status: Unknown
• Conditions: Cesarean Section; Postnatal Pulmonary Adaptation
• Intervention / Treatment: Drug: Placebo; Drug: salbutamol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Women's Hospital
    • Contact: Cecilia Janér, MD; Phone Number: +35894711; Email: cecilia.janer@helsinki.fi
    • Contact: Otto M Helve, MD, PhD; Phone Number: +358505824426; Email: otto.helve@helsinki.fi
    • Sub-Investigator: Cecilia Janér, MD
    • Sub-Investigator: Otto M Helve, MD, PhD
    • Principal Investigator: Sture Andersson, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sture Andersson
• Investigators: Principal Investigator: Sture Andersson, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: October 31, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Albuterol; Salbutamol; Postnatal adaptation; Lung fluid; Epithelial Sodium Channel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: SAISTY-1