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Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants (SIMPLSAFE3)

C

Charles University, Czech Republic

Status

Begins enrollment in 2 months

Conditions

Premature; Infant

Treatments

Device: High-flow-nasal-cannula

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.

Full description

Background and Rationale

Non-invasive CPAP is recommended for stabilizing premature newborns, but its optimal pressure is unknown. Higher pressures without spontaneous breathing lead to PPV, which can damage immature lungs and cause complications. Frequent mask adjustments needed for CPAP can stimulate reflexes that exacerbate bradycardia.

HFNC offers a less disruptive alternative, reducing trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness in some premature infants. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for PPV, and support safe and effective stabilization of very premature infants (VPIs).

Hypothesis HFNC reduces upper airway resistance and provides adequate pressure for lung clearance in very immature, spontaneously ventilating neonates. Less irritation compared to CPAP may reduce PPV needs, promoting smooth lung aeration and cardiopulmonary stabilization in very preterm infants.

Trial Aim Compare the effectiveness and safety of HFNC and CPAP in the delivery room and during transport to the NICU in severely premature neonates. The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth.

Objectives The primary objective is to compare the effectiveness of HFNC and CPAP in reducing PPV needs in very premature infants immediately after birth.

Study Design A stepped-wedge cluster randomized controlled trial where participating centers are randomized to use both HFNC and CPAP during different periods.

Study Population Setting

10 tertiary referral centers for perinatal care (9 in the Czech Republic, 1 in Slovakia).

Participants

Very premature infants delivered between 28+0 and 31+6 weeks gestation.

Inclusion Criteria

Gestational age between 28+0 and 31+6 weeks. Written informed consent from parents/legal guardians. Exclusion Criteria

Peripartal hypoxia with pH < 7.1. Significant congenital malformations. IUGR with estimated weight below 800g. Conditions affecting breathing/ventilation or oxygenation. Decision for palliative neonatal care. Sample Size Calculation To detect a 15% relative decrease in PPV administration, approximately 443 patients are required. The trial will include five clusters, each recruiting 15 patients per period over 6-10 periods (90 days each).

Recruitment and Consent Centers will be randomized to either CPAP or HFNC at each time period. Parental consent will be obtained before birth, ensuring parents are adequately informed.

Method Primary Endpoint

Proportion of neonates requiring PPV within the first 10 minutes post-birth. Secondary Endpoints

Achieving SpO2 > 80% within 5 minutes without PPV. Achieving SpO2 > 90% with FiO2 ≤ 0.40 within 10 minutes without PPV. Stabilization on selected ventilatory support with FiO2 ≤ 0.35 without PPV at 3 hours of life.

Enrollment

443 estimated patients

Sex

All

Ages

1 to 5 minutes old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infants will be enrolled if they delivered between 28+0 and 31+6 weeks gestation in one of the participating centers. The gestational age of infants was calculated according to the first trimester screening. Written informed consent from parent/legal guardian(s) is obtained before delivery. Infants of multiple gestations and of either sex are eligible to be enrolled

Exclusion criteria

Peripartal hypoxia with pH < 7,1 Significant congenital malformations. IUGR with estimated weight of fetus below 800g. Condition that has an adverse effect on breathing/ventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.

A documented decision to give palliative neonatal care.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

443 participants in 2 patient groups

ARM A (CPAP group)
No Intervention group
Description:
Infants randomized to the ARM A group will be stabilized on CPAP, according to the standard procedure of each participating center.
ARM B (HFNC group)
Experimental group
Description:
For infants randomly assigned to the ARM B group, the respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula.
Treatment:
Device: High-flow-nasal-cannula

Trial contacts and locations

0

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Central trial contact

Tereza Lamberska, PhD

Data sourced from clinicaltrials.gov

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