Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT01978418
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2013-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Salbutamol in Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth', 'timeFrame': '6 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age', 'timeFrame': '6 hours', 'description': 'To evaluate whether lung compliance of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.'}, {'measure': 'Decrease in respiratory rate at 3-6 hours of age', 'timeFrame': '6 hours', 'description': 'To see whether respiratory rate is decreased in infants receiving salbutamol at 30-60 minutes of age'}, {'measure': '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', 'timeFrame': '6 hours'}, {'measure': 'Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age', 'timeFrame': '6 hours of age', 'description': 'whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung fluid', 'Postnatal adaptation', 'Salbutamol', 'Albuterol', 'Epithelial Sodium Channel'], 'conditions': ['Postnatal Pulmonary Adaptation', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy singleton pregnancy\n* Cesarean section at 37 + 0 to 41 + 6 gestational weeks\n\nExclusion Criteria:\n\n* clinically significant congenital malformations\n* birth weight \\< 2000 grams\n* intubation\n* 200 bp for more than 5 min\n* relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids\n* the suspicion of/confirmed pneumothorax or infection'}, 'identificationModule': {'nctId': 'NCT01978418', 'acronym': 'SAISTY', 'briefTitle': 'Inhaled Salbutamol in Elective Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Inhaled Salbutamol in Elective Caesarean Section', 'orgStudyIdInfo': {'id': 'SAISTY-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is administered once, at 30-60 minutes of age', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Salbutamol 0,4 mg inhalation, given once at 30-60 minutes of age', 'interventionNames': ['Drug: salbutamol']}], 'interventions': [{'name': 'salbutamol', 'type': 'DRUG', 'otherNames': ['Inhaled Ventoline (Evohaler) 0,1 mg/dos'], 'description': 'Medication given once as a dose of 4 puffs at 30-60 minutes of age', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo, manufactured by GSK Finland'], 'description': 'Placebo given once as a dose of four puffs at 30-60 minutes of age', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Cecilia Janér, MD', 'role': 'CONTACT', 'email': 'cecilia.janer@helsinki.fi', 'phone': '+35894711'}, {'name': 'Otto M Helve, MD, PhD', 'role': 'CONTACT', 'email': 'otto.helve@helsinki.fi', 'phone': '+358505824426'}, {'name': 'Cecilia Janér, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Otto M Helve, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sture Andersson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Women's Hospital", 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Cecilia Janér, MD', 'role': 'CONTACT', 'email': 'cecilia.janer@helsinki.fi', 'phone': '+35894711'}, {'name': 'Otto M Helve, MD, PhD', 'role': 'CONTACT', 'email': 'otto.helve@helsinki.fi', 'phone': '+358505824426'}], 'overallOfficials': [{'name': 'Sture Andersson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sture Andersson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor in Neonatology', 'investigatorFullName': 'Sture Andersson', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}