Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial.

Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial. - LATE-REC-SURF

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004720-38-IT

Enrollment

Registered

2020-10-21

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Preterm infants still requiring mechanical ventilation at 7-10 days of life. MedDRA version: 20.0 Level: LLT Classification code 10076729 Term: Very preterm infant System Organ Class: 100000004868

Interventions

Trade Name: CUROSURF Product Name: PORACTANT Product Code: [R07AA02] Pharmaceutical Form: Endotracheopulmonary instillation, suspension INN or Proposed INN: FRAZIONE FOSFOLIPIDICA DA POLMONE SUINO CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Extremely low gestational age newborn infants (GA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Major congenital malformation (i.e., infants with genetic, metabolic or endocrine disorder diagnosed before enrolment) 2. High index of suspicion of infection before enrolment 3. Neurological conditions that might contraindicate extubation 4. Inotropic agents needed 5. Pneumothorax 6. Hemodynamically significant ductus arteriosus 7. Surgical intervention within the past 72 hours 8. Partecipation in another interventional clinical study that may interfere with the results of this trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation.;Secondary Objective: Key secondary objective: To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the rate of bronchopulmonary dysplasia.;Primary end point(s): First successful extubation (day of life) defined as extubation not followed by a reintubation for at least 7 days.;Timepoint(s) of evaluation of this end point: Extubation will be considered successful when adequate spontaneous respiration will be maintained for at least 7 days.	—

Measure

Time frame

Main Objective: To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation.;Secondary Objective: Key secondary objective: To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the rate of bronchopulmonary dysplasia.;Primary end point(s): First successful extubation (day of life) defined as extubation not followed by a reintubation for at least 7 days.;Timepoint(s) of evaluation of this end point: Extubation will be considered successful when adequate spontaneous respiration will be maintained for at least 7 days.

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary end-point: Rate of bronchopulmonary dysplasia expressed as the oxygen-dependance at 36 weeks of post-menstrual age.;Timepoint(s) of evaluation of this end point: From birth to discharge.	—

Countries

Italy

Contacts

Public ContactDIREZIONE SCIENTIFICA

FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS

direzione.scientifica@poiliclinicogemelli.it0630155701

Outcome results

None listed

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