Status:
UNKNOWN
Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Meconium Aspiration Syndrome
Eligibility:
All Genders
1-24 years
Phase:
PHASE3
Brief 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 co...
Detailed Description
Meconium-stained amniotic fluid occurs in about 5 to 20% of all births in the United States, with meconium aspiration syndrome occuring in approximately 5% of these infants. In this disease process, m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00312507
Start Date
April 1 2006
Last Update
October 17 2006
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8