NCT01978418

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

October 31, 2013

Last Update Submit

December 5, 2014

Conditions

Postnatal Pulmonary AdaptationCesarean Section

Keywords

Lung fluidPostnatal adaptationSalbutamolAlbuterolEpithelial Sodium Channel

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 hours

Secondary Outcomes (4)

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

    6 hours

  • Decrease in respiratory rate at 3-6 hours of age

    6 hours

  • 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

    6 hours

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

    6 hours of age

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Intervention

ACTIVE COMPARATOR

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

Drug: salbutamol

Interventions

salbutamolDRUG

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

Also known as: Inhaled Ventoline (Evohaler) 0,1 mg/dos
Intervention
PlaceboDRUG

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

Also known as: Placebo, manufactured by GSK Finland
Placebo

Eligibility Criteria

AgeUp to 1 Hour
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy singleton pregnancy
  • Cesarean section at 37 + 0 to 41 + 6 gestational weeks

You may not qualify if:

  • clinically significant congenital malformations
  • birth weight \< 2000 grams
  • intubation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Sture Andersson, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Janér, MD

CONTACT

+35894711cecilia.janer@helsinki.fi

Otto M Helve, MD, PhD

CONTACT

+358505824426otto.helve@helsinki.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in Neonatology

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

FI(1)