High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Very Premature Infants: a Prospective Observational Study (SIMPLSAFE)

November 8, 2024 updated by: Jonáš Klára, Charles University, Czech Republic
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech
      • Praha, Czech, Czechia, 12808
        • Charles University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants born between 28+0 and 31+6 gestational weeks were enrolled in the study after obtaining parental informed consent.

Exclusion Criteria:

  • Infants with congenital malformations, previable rupture of membranes, and acute intrauterine hypoxia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow-nasal-cannula
In this study, very preterm infants receive High-Flow Nasal Cannula therapy immediately after birth. The intervention includes placental transfusion, followed by administering High-Flow Nasal Cannula at a flow rate of 8 l/min along with intermittent tactile stimulation. Criteria for switching to Continuous Positive Airway Pressure or Positive Pressure Ventilation are established for cases of persistent bradycardia or low SpO2.
Device: High-Flow Nasal Cannula
The intervention involves administering High-Flow Nasal Cannula therapy to very preterm infants immediately after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HFNC slabilization
Time Frame: 10 minutes after delivery
Number of infants who were stabilized after birth on high flow nasal cannula exclusively without any other use of artificial external pressures.
10 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/21

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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