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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06458582

Acronym

SIMPLSAFE

Enrollment

Registered

2024-06-13

Start date

2021-02-01

Completion date

2022-12-31

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature; Infant

Keywords

neonatology, HFNC, prematurity

Brief 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.

Interventions

DEVICEHigh-Flow Nasal Cannula

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Minutes to 2 Minutes

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.

Design outcomes

Primary

Measure	Time frame	Description
HFNC slabilization	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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026