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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Completed

Conditions: Respiratory Morbidity; Respiratory Distress Syndrome, Newborn; Transient Tachypnea of the Newborn

Treatments: Other: Sustained Inflation

Study type: Interventional

Funder types: Other

Identifiers

NCT03165305

123

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: Under 2 minutes old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• term newborns
• parental informed consent
• inborn infants

Exclusion criteria

• major congenital/chromosomal abnormalities
• lack of informed consent
• outborn infants
• Premature infants

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Sustained Inflation Group

Experimental group

Description:

Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.

Treatment:

Other: Sustained Inflation

No Intervention group

No Intervention group

Description:

Includes routine neonatal care in the delivery room