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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn; Respiratory Morbidity; Transient Tachypnea of the Newborn
• Intervention / Treatment: Other: Sustained Inflation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• term newborns
• parental informed consent
• inborn infants

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sustained Inflation Group; Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.	Other: Sustained Inflation; Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.
No Intervention: No Intervention group; Includes routine neonatal care in the delivery room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Morbidity	RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support	2 hours

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No