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NCT03165305 Clinical Trial

The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03165305
Other study ID # 123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2019

Study information
Verified date August 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 1, 2019
Est. primary completion date May 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Minutes
Eligibility Inclusion Criteria:

- term newborns

- parental informed consent

- inborn infants

Exclusion Criteria:

- major congenital/chromosomal abnormalities

- lack of informed consent

- outborn infants

- Premature infants

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sustained Inflation
Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Morbidity RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support 2 hours
See also
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