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.

Phase 1

• Conditions: Preterm infants still requiring mechanical ventilation at 7-10 days of life.; MedDRA version: 20.0Level: LLTClassification code 10076729Term: Very preterm infantSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2019-004720-38-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Extremely low gestational age newborn infants (GA < 28 weeks) – gestational age matching between maternal dates and/or early antenatal ultrasound
2.Singleton or multiple birth
3.Postnatal age between 7 and 10 days
4.Invasive mechanical ventilation still needed
5.Fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours
6.Stable cardiovascular condition
7.Informed consent form signed by parents or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary end-point:<br>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.