REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give surfactant, a substance that helps keep the lungs of premature infants open, to those suffering from Respiratory Distress Syndrome (RDS). The goal is to see if using a special measurement of lung function can reduce the time these infants need respiratory support, compared to the usual method. This study will involve infants born between 27 and 32 weeks of pregnancy who need help breathing but are still able to breathe on their own. To participate, parents will need to give their written consent, and infants must meet certain health criteria, such as requiring non-invasive breathing support.

If eligible, infants will be randomly assigned to one of two groups: one will receive surfactant based on standard clinical assessments, while the other will receive it using both lung function measurements and clinical assessments. Throughout the study, infants will be monitored closely, and the research will take place in neonatal intensive care units. The trial is not yet recruiting participants, but it aims to improve care for premature infants by exploring whether this new approach can lead to better outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Gestational age (GA) ≥ 27+0 and \< 33+0 weeks
• • 2. Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 \>0.30 for target SpO2 88-93% or Silverman score ≥ 5.
• • 3. Inborn
• • 4. Written parental consent obtained
• • 5. Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care
• Exclusion Criteria:
• • 1. Major congenital anomalies
• • 2. Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
• • 3. Surfactant therapy prior to the study entry
• • 4. Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH \< 7.0 or base excess (BE) \< -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
• • 5. Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations...)
• • 6. Any clinical condition which may place the infants at undue risk as deemed by clinicians
• • 7. Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
• • 8. Outborn patients