Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this pilot study is to examine the feasibility and safety of performing a larger trial to assess outcomes following treatment of meconium aspiration syndrome with surfactant lavage compared to bolus surfactant. Specifically, we will determine if surfactant lavage results in a more rapid improvement in physiologic outcomes (e.g. pulmonary compliance), as well as clinical outcomes (e.g. length of time on mechanical ventilation).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Pulmonary Surfactants

Criteria

Inclusion Criteria:

• infants ≥ 36 weeks gestational age with evidence of meconium aspiration syndrome

• respiratory support (ventilator or CPAP) within 6 h of birth

• enrolment within 24 h of birth

• significant difficulty with oxygenation, as indicated by an oxygenation index (OI) > 15, where OI = (FiO2 x MAP) / PaO2 and MAP is the mean airway pressure

• presence of an arterial line

Exclusion Criteria:

• major congenital anomalies

• known antenatal diagnosis of significant congenital heart disease (diagnosis other than patent foramen ovale, patent ductus arteriosus or small ventricular septal defect)

• infants with a maternal history of oligohydramnios and physical features consistent with the diagnosis

• surfactant administration prior to enrolment

• hemodynamic instability defined as intractable hypotension on more than 2 inotropes

• significant pulmonary hemorrhage, defined as pulmonary hemorrhage in association with a 30% (absolute) increase in FiO2 and radiologic changes consistent with pulmonary hemorrhage

• significant intracranial hemorrhage, defined as a unilateral or bilateral Grade III or IV intraventricular hemorrhage or a large intracranial, non-intraventricular hemorrhage

• significant illness meeting ECMO criteria with an OI > 40

• infants in whom withdrawal of intensive care is likely