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NCT05609877
The NONA-LISA Trial
Conditions: Respiratory Distress Syndrome in Premature Infant
Sex: All
Ages: 24 Weeks – 30 Weeks
Phase: NA
Enrollment: 324
Sponsor: Rigshospitalet, Denmark
Location: Denmark
Summary
The NONA-LISA trial will be an investigator-initiated, multicentre, pragmatic, parallel-group, blinded RCT conducted at four university hospitals across Denmark.
A total of 324 inborn premature infants will be included within 36 months at four neonatal intensive care units (NICUs) across Denmark (approximately 2 infants per month per unit).The aim is to compare LISA using a non-pharmacological approach alone with routine analgesic treatment combined with a non-pharmacological approach (according to local guidelines) regarding LISA failure defined as the need for positive pressure ventilation for 30 min or more (cumulated) within 24 hours after the procedure in infants born prior to 30 gestational weeks.
Eligibility Criteria
Inclusion Criteria:Inborn infants with a gestational age of 24+0 to 29+6 weeks and meeting the criteria for surfactant treatment by LISA.Exclusion Criteria:PPROM >3 weeks and suspicion of oligohydramnion or lung hypoplasia.Requiring MV or intubation at any time before LISA.Suspicion of pneumothorax or pulmonary haemorrhage or effusion.Major congenital malformation (e.g., CDH and oesophagus atresia) or chromosomal abnormality or inherited disorders of metabolism.
Source: ClinicalTrials.gov (NCT05609877). StuddyBuddy aggregates publicly available trial information.