MedTrace Logo

Inhaled Salbutamol in Elective Caesarean Section

NCT01978418 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2014-12-08

No results posted yet for this study

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).

Conditions

  • Postnatal Pulmonary Adaptation
  • Cesarean Section

Interventions

DRUG

salbutamol

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Sture Andersson

    lead OTHER

Principal Investigators

  • Sture Andersson, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Hour
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01978418 on ClinicalTrials.gov