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Inhaled Salbutamol in Elective Caesarean Section

Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postnatal Pulmonary Adaptation; Cesarean Section

Intervention: salbutamol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sture Andersson

Official(s) and/or principal investigator(s):
Sture Andersson, MD, PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital

Overall contact:
Cecilia Janér, MD, Phone: +35894711, Email: cecilia.janer@helsinki.fi

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).

Clinical Details

Official title: Inhaled Salbutamol in Elective Caesarean Section

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

Primary outcome: To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth

Secondary outcome:

To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age

Decrease in respiratory rate at 3-6 hours 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

Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age

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

Minimum age: N/A. Maximum age: 1 Hour. Gender(s): Both.

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

Locations and Contacts

Cecilia Janér, MD, Phone: +35894711, Email: cecilia.janer@helsinki.fi

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

Starting date: November 2013
Last updated: December 5, 2014

Page last updated: August 23, 2015

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