Back to resultsThe Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Primary Purpose
Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sustained Inflation
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Distress Syndrome, Newborn
Eligibility Criteria
Inclusion Criteria:
- term newborns
- parental informed consent
- inborn infants
Exclusion Criteria:
- major congenital/chromosomal abnormalities
- lack of informed consent
- outborn infants
- Premature infants
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sustained Inflation Group
No Intervention group
Arm Description
Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.
Includes routine neonatal care in the delivery room
Outcomes
Primary Outcome Measures
Respiratory Morbidity
RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support
Secondary Outcome Measures
Full Information
NCT ID
NCT03165305
First Posted
May 23, 2017
Last Updated
August 12, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03165305
Brief Title
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Official Title
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sustained Inflation Group
Arm Type
Experimental
Arm Description
Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.
Arm Title
No Intervention group
Arm Type
No Intervention
Arm Description
Includes routine neonatal care in the delivery room
Intervention Type
Other
Intervention Name(s)
Sustained Inflation
Intervention Description
Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.
Primary Outcome Measure Information:
Title
Respiratory Morbidity
Description
RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support
Time Frame
2 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
term newborns
parental informed consent
inborn infants
Exclusion Criteria:
major congenital/chromosomal abnormalities
lack of informed consent
outborn infants
Premature infants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merih Cetinkaya
Organizational Affiliation
Kanuni Sultan Suleyman Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
İstanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
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