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High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06683677
Acronym
SIMPLSAFE2
Enrollment
60
Registered
2024-11-12
Start date
2024-12-01
Completion date
2029-07-01
Last updated
2024-11-14

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

Conditions

High Flow Nasal Canula, Premature Infant, Ventilation Therapy

Brief summary

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 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 Saturation of oxygen (SpO2).

Interventions

DEVICEHigh-Flow Nasal Cannula

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

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Minutes to 2 Minutes
Healthy volunteers
No

Inclusion criteria

* Preterm infants born between 25+0 and 27+6 gestational weeks * Weight above 500 grams

Exclusion criteria

* Previable rupture of membranes, * Congenital malformations previable * Acute intrauterine hypoxia.

Design outcomes

Primary

MeasureTime frameDescription
Positive pressure ventilation after delivery10 minutesThe number of infants who required positive pressure ventilation (PPV) in the first ten minutes after delivery.

Secondary

MeasureTime frameDescription
SpO₂ > 80% in five minutes after delivery5 minutesThe number of infants with SpO₂ \> 80% five minutes after delivery, with or without the use of positive pressure ventilation (PPV).
SpO₂ > 90% ten minutes after delivery10 minutesThe number of infants with SpO₂ \> 90% ten minutes after delivery without the use of positive pressure ventilation (PPV).

Countries

Czechia

Contacts

Primary ContactKlára Jonáš
klara.jonas@vfn.cz00420602504067
Backup ContactRichard Plavka
Richard.Plavka@vfn.cz

Outcome results

None listed

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