Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03165305
  4. Details
NCT03165305 Clinical Trial

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

Respiratory Distress Syndrome, Newborn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03165305
Other study ID # 123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2019

Study information
Verified date August 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 1, 2019
Est. primary completion date May 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Minutes
Eligibility Inclusion Criteria:

- term newborns

- parental informed consent

- inborn infants

Exclusion Criteria:

- major congenital/chromosomal abnormalities

- lack of informed consent

- outborn infants

- Premature infants

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sustained Inflation
Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Morbidity RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support 2 hours
See also
  Status Clinical Trial Phase
Recruiting NCT01206946 - Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants Phase 2
Completed NCT00739115 - The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT01242462 - Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial Phase 1/Phase 2
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Completed NCT00486850 - Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress Phase 4
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Completed NCT05796128 - NIPPV vs.nCPAP During LISA Procedure N/A
Withdrawn NCT02835209 - Positioning During SBT in NICU Infants N/A
Terminated NCT01467076 - Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF) Phase 2
Completed NCT00828243 - Genetic Regulation of Surfactant Deficiency
Completed NCT00556738 - Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn N/A
Not yet recruiting NCT05594030 - Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Completed NCT02332304 - Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity. Phase 3
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT04137783 - ABCA3 Gene and RDS in Late Preterm and Term Infants
Completed NCT01941524 - Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations Phase 4
Completed NCT01102543 - Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS) N/A
Completed NCT00501982 - Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Phase 4