High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants: A Prospective Observational Study

Premature; Infant Clinical Trial

— SIMPLSAFE  

Official title:

High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458582
• Other study ID #: 16/21
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Minutes to 2 Minutes

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature; Infant

Intervention

Device:
• High-Flow Nasal Cannula
The intervention involves administering High-Flow Nasal Cannula therapy to very preterm infants immediately after birth.

Locations

Country	Name	City	State
Czechia	Charles University in Prague	Praha	Czech

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HFNC slabilization	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