Medium vs Low Oxygen Threshold for the Surfactant Administration

Virgilio Paolo Carnielli

Status and phase: Not yet enrolling; Phase 4

Conditions: Respiratory Distress Syndrome

Treatments: Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT04199364

2535

2019-002923-13 (EudraCT Number)

Details and patient eligibility

About

The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.

Full description

Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear.

In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.

Enrollment: 200 estimated patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age less than 32 weeks;
• diagnosis of respiratory distress (RDS);
• need for ventilatory support;
• written informed consent.

Exclusion criteria

• congenital malformations;
• genetic disorders;
• perinatal asphyxia.
• neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Low FiO2 threshold

Experimental group

Description:

A fraction of inspired oxygen (FiO2) of 25% to have an oxygen saturation (SpO2) of 90-92%.

Treatment:

Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension

Medium FiO2 threshold

Experimental group

Description:

A fraction of inspired oxygen (FiO2) of 35% to have an oxygen saturation (SpO2) of 90-92%.

Treatment:

Drug: Poractant Alfa 80 mg/mL Intratracheal Suspension