MULTICENTRE RANDOMISED CONTROLLED TRIAL OF MINIMALLY-INVASIVE SURFACTANT THERAPY IN PRETERM INFANTS 25-28 WEEKS GESTATION ON CONTINUOUS POSITIVE AIRWAY PRESSURE

MULTICENTRE RANDOMISED CONTROLLED TRIAL OF MINIMALLY-INVASIVE SURFACTANT THERAPY IN PRETERM INFANTS 25-28 WEEKS GESTATION ON CONTINUOUS POSITIVE AIRWAY PRESSURE - OPTIMIST-A TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44166

Enrollment

Registered

2016-06-20

Start date

2016-07-04

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

respiratoire insufficientie respiratory distress syndrome (RDS)

Interventions

Infants randomised to surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, at a dosage of 200 mg/kg.

Respiratory Distress Syndrome

Surfactant

Continuous positive airway pressure

Preterm infants

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Preterm infants 25-28 weeks gestation 2. Requiring CPAP or nasal IPPV because of respiratory distress. 3. CPAP pressure of 5-8 cm H2O and Fi (fractional inspiratory) O2 * 0.30. 4. Less than 6 hours of age. 5. Agreement of the Treating Physician in charge of the infant*s care. 6. Signed parental consent.

Exclusion criteria

Exclusion criteria: 1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis. 2. Congenital anomaly or condition that might adversely affect breathing. 3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia). 4. Lack of availability of an OPTIMIST treatment team.

Design outcomes

Primary

Measure	Time frame
Primary outcome: Incidence of composite outcome of death or physiological bronchopulmonary dysplasia (BPD).	—

Secondary

Measure	Time frame
Secondary outcomes: Incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years.	—

Measure

Time frame

Secondary outcomes: Incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)