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

NCT ID: NCT03165305

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-06-01

Brief Summary

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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

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Conditions

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Respiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn Respiratory Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sustained Inflation Group

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

Group Type EXPERIMENTAL

Sustained Inflation

Intervention Type OTHER

Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.

No Intervention group

Includes routine neonatal care in the delivery room

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sustained Inflation

Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* term newborns
* parental informed consent
* inborn infants

Exclusion Criteria

* major congenital/chromosomal abnormalities
* lack of informed consent
* outborn infants
* Premature infants
Maximum Eligible Age

2 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merih Cetinkaya

Associate Professor, MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merih Cetinkaya

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Training and Research Hospital

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id

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