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

Not Applicable

Completed

• Conditions: Transient Tachypnea of the Newborn; Respiratory Morbidity; Respiratory Distress Syndrome, Newborn
• Interventions: Other: Sustained Inflation

• Registration Number: NCT03165305
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Study Start: 2018-04-01
• Primary Completion: 2019-05-05
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• term newborns
• parental informed consent
• inborn infants

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Respiratory Morbidity	2 hours	RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 İstanbul, Turkey