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Inhaled salbutamol in elective caesarean section

Inhaled salbutamol in elective caesarean section

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001912-53-FI
Enrollment
62
Registered
2012-11-06
Start date
2012-11-09
Completion date
Unknown
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal pulmonary adaptation

Interventions

Trade Name: Ventoline Evohaler Product Name: Ventoline Evohaler Product Code: R03AC02 Pharmaceutical Form: Inhalation vapour, solution I

Sponsors

Children's Hospital, Helsinki University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study population consists of 62 healthy singleton newborn infants delivered by elective cesarean section at 37 + 0 to 41+6 gestational weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 62 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) clinically significant congenital malformations, 2) birth weight 200 bp for more than 5 min, 5) relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids and 6) the suspicion of/confirmed pneumothorax or infection

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim of this study is to evaluate whether the respiratory status, measured by a transthoracal ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.;Secondary Objective: To study whether infants at risk of developing transient tachypnea of the newborn can be identified early using a transthoracal ultrasound method.;Primary end point(s): Lung compliance and Ultrasound measurements at 3-6 hours of age.;Timepoint(s) of evaluation of this end point: 3-6 hours of age

Secondary

MeasureTime frame
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: No time for this end point

Countries

Finland

Contacts

Public ContactChildren's Hospital

Children's Hospital

35894711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026