NCT03165305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

May 23, 2017

Last Update Submit

August 12, 2019

Conditions

Respiratory Distress Syndrome, NewbornTransient Tachypnea of the NewbornRespiratory Morbidity

Outcome Measures

Primary Outcomes (1)

  • Respiratory Morbidity

    RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support

    2 hours

Study Arms (2)

Sustained Inflation Group

EXPERIMENTAL

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

Other: Sustained Inflation

No Intervention group

NO INTERVENTION

Includes routine neonatal care in the delivery room

Interventions

Sustained InflationOTHER

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

Sustained Inflation Group

Eligibility Criteria

AgeUp to 2 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • term newborns
  • parental informed consent
  • inborn infants

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornTransient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTachypneaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Merih Cetinkaya

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD,PhD

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

April 1, 2018

Primary Completion

May 5, 2019

Study Completion

June 1, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)