Inhaled Salbutamol in Elective Caesarean Section (SAISTY)

This study is currently recruiting participants.
Verified December 2013 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Sture Andersson, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01978418
First received: October 31, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Postnatal Pulmonary Adaptation
Cesarean Section
Drug: salbutamol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inhaled Salbutamol in Elective Caesarean Section

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    To evaluate whether lung compliance of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.

  • Decrease in respiratory rate at 3-6 hours of age [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    To see whether respiratory rate is decreased in infants receiving salbutamol at 30-60 minutes of age

  • 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 [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age [ Time Frame: 6 hours of age ] [ Designated as safety issue: No ]
    whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age


Estimated Enrollment: 62
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Inhaled Ventoline (Evohaler) 0,1 mg/dos

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

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978418

Contacts
Contact: Cecilia Janér, MD +35894711 cecilia.janer@helsinki.fi
Contact: Otto M Helve, MD, PhD +358505824426 otto.helve@helsinki.fi

Locations
Finland
Women's Hospital Recruiting
Helsinki, Finland, 00029
Contact: Cecilia Janér, MD    +35894711    cecilia.janer@helsinki.fi   
Contact: Otto M Helve, MD, PhD    +358505824426    otto.helve@helsinki.fi   
Sub-Investigator: Cecilia Janér, MD         
Sub-Investigator: Otto M Helve, MD, PhD         
Principal Investigator: Sture Andersson, MD, PhD         
Sponsors and Collaborators
Sture Andersson
Investigators
Principal Investigator: Sture Andersson, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Sture Andersson, Professor in Neonatology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01978418     History of Changes
Other Study ID Numbers: SAISTY-1
Study First Received: October 31, 2013
Last Updated: December 4, 2013
Health Authority: Fimea: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Lung fluid
Postnatal adaptation
Salbutamol
Albuterol
Epithelial Sodium Channel

Additional relevant MeSH terms:
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014