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

Charles University, Czech Republic

Status: Completed

Conditions: Premature; Infant

Treatments: Device: High-Flow Nasal Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT06458582

16/21

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: Under 2 minutes old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

High-flow-nasal-cannula

Experimental group

Description:

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.

Treatment:

Device: High-Flow Nasal Cannula