Eine randomisierte kontrollierte Studie zum Vergleich einer prophylaktischen mit einer selektiven wenig invasiven Surfactant Therapie bei Frühgeborenen Eine multizentrische Phase IV Studie.

A randomized controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (PRO-LISA)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005495-19-DE

Enrollment

698

Registered

2021-10-19

Start date

2022-01-19

Completion date

Unknown

Last updated

2024-08-05

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

Conditions

Respiratory distress syndrome of premature infants

Interventions

Trade Name: Curosurf Product Name: Surfactant Product Code: R07A Pharmaceutical Form: Endotracheopulmonary instillation INN or Proposed INN: Phospholipids from pork lung Other descriptive name: PORCIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age at birth 25 weeks + 0 days to 28 weeks + 6 days Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Lethal malformations or lethal conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: We here propose to test prophylactic treatment with LISA within the first hour of life (intervention group) compared to a selective treatment with surfactant (via LISA or via an endotracheal tube) if supplemental oxygen requirement exceeds 30% or respiratory distress is worsening (control group). The primary endpoint of the trial is forced expiratory volume within one second (FEV1) at 5 years of age.;Secondary Objective: To study the long term effects of prophylactic surfactant treatment on lung function and general health of preterm infants.;Primary end point(s): Forced expiratory volume within one second (FEV1) z-score calculated according to "Global Lung Function Initiative (GLI)" standards.;Timepoint(s) of evaluation of this end point: At age 5 years	—

Measure

Time frame

Main Objective: We here propose to test prophylactic treatment with LISA within the first hour of life (intervention group) compared to a selective treatment with surfactant (via LISA or via an endotracheal tube) if supplemental oxygen requirement exceeds 30% or respiratory distress is worsening (control group). The primary endpoint of the trial is forced expiratory volume within one second (FEV1) at 5 years of age.;Secondary Objective: To study the long term effects of prophylactic surfactant treatment on lung function and general health of preterm infants.;Primary end point(s): Forced expiratory volume within one second (FEV1) z-score calculated according to "Global Lung Function Initiative (GLI)" standards.;Timepoint(s) of evaluation of this end point: At age 5 years

—

Secondary

Measure	Time frame
Secondary end point(s): Forced vital capacity (FVC), FEV1/FVC, running distance within 3 minutes, obstructive bronchitis within the last 12 months, cerebral pals, movement battery for children score, IQ (WPPSI IV).;Timepoint(s) of evaluation of this end point: At age 5 years	—

Countries

Germany

Contacts

Public ContactChildrens Hospital

University Hospital Schleswig-Holstein

maria.klingenberg@uksh.de004945150043050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026