Status:
UNKNOWN
Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial
Lead Sponsor:
VENTO GIOVANNI
Conditions:
Bronchopulmonary Dysplasia
Chronic Pulmonary Insufficiency of Prematurity
Eligibility:
All Genders
7-10 years
Phase:
PHASE2
Brief Summary
This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS. The aim of the study is to test the hypothesis th...
Detailed Description
Rationale and plausibility of the study. Despite the recent advances in perinatal care, bronchopulmonary dysplasia (BPD) still represents one of the most devastating conditions in premature infants wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 9\. Known hypersensitivity to the drug or to one of the excipients
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04825197
Start Date
December 1 2021
End Date
February 1 2025
Last Update
December 7 2021
Active Locations (1)
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1
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, Italy, 00168