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Inhaled Salbutamol in Elective Caesarean Section

NCT ID: NCT01978418

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Postnatal Pulmonary Adaptation Cesarean Section

Keywords

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Lung fluid Postnatal adaptation Salbutamol Albuterol Epithelial Sodium Channel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo is administered once, at 30-60 minutes of age

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given once as a dose of four puffs at 30-60 minutes of age

Intervention

Salbutamol 0,4 mg inhalation, given once at 30-60 minutes of age

Group Type ACTIVE_COMPARATOR

salbutamol

Intervention Type DRUG

Medication given once as a dose of 4 puffs at 30-60 minutes of age

Interventions

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salbutamol

Medication given once as a dose of 4 puffs at 30-60 minutes of age

Intervention Type DRUG

Placebo

Placebo given once as a dose of four puffs at 30-60 minutes of age

Intervention Type DRUG

Other Intervention Names

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Inhaled Ventoline (Evohaler) 0,1 mg/dos Placebo, manufactured by GSK Finland

Eligibility Criteria

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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
Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sture Andersson

OTHER

Sponsor Role lead

Responsible Party

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Sture Andersson

Professor in Neonatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sture Andersson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Women's Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Cecilia Janér, MD

Role: CONTACT

Phone: +35894711

Email: [email protected]

Otto M Helve, MD, PhD

Role: CONTACT

Phone: +358505824426

Email: [email protected]

Facility Contacts

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Cecilia Janér, MD

Role: primary

Otto M Helve, MD, PhD

Role: backup

Other Identifiers

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SAISTY-1

Identifier Type: -

Identifier Source: org_study_id