Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

Meconium Aspiration Syndrome Clinical Trial

Official title:

Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00312507
• Other study ID #: 1000007730
• Status: Recruiting
• Phase: Phase 3
• First received: April 6, 2006
• Last updated: October 16, 2006
• Start date: April 2006

Study information

• Verified date: October 2006
• Source: The Hospital for Sick Children
• Contact: Patrick McNamara, MD
• Phone: 416-813-5773
• Email: patrick.mcnamara[@]sickkids.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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, meconium is believed to mechanically obstruct the airways, causing a chemical pneumonitis and inactivate surfactant. Approximately one-third of these babies need mechanical ventilation and approximately 5% die. Since 1990 surfactant has been the standard of care for treatment of respiratory distress syndrome. Pulmonary compliance and gas exchange often improve rapidly after administration of surfactant. Its use has led to significantly reduced mortality rates and improved short-term respiratory function. There is evidence to support its use in other neonatal respiratory disorders where there is dysfunction or inactivation of surfactant. Its use in meconium aspiration syndrome is the most well-studied alternate use to date. The Canadian Pediatric Society's (2005) position statement recommends that infants with meconium aspiration syndrome who are intubated and require more than 50% oxygen should receive exogenous surfactant therapy.

Studies in both animals and humans suggest that surfactant helps in meconium aspiration, either administered as a bolus or as a lavage. There have been no trials to date comparing the efficacy of surfactant lavage to bolus surfactant in human neonates with meconium aspiration or examining the physiologic effects of surfactant, given as either a bolus or lavage, in the treatment of meconium aspiration syndrome. This study will assess the relative efficacy of these two methods of administering surfactant and their effect on physiologic and clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome

Intervention

Drug:
• Bovine Lipid Extract Surfactant (administered by lavage)

• Bovine Lipid Extract Surfactant (administered by bolus)

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change in oxygenation indices from baseline to 1 and 6 h following treatment
Primary	% change in dynamic pulmonary compliance from baseline to 1 and 6 h following treatment
Primary	% change in pulmonary artery pressure from baseline to 1 and 6 h following treatment
Primary	measures of efficacy of ventilation and oxygenation at 1 h and 6 h following treatment
Primary	cardiac function by echocardiography at 6 hours following treatment
Secondary	% change in oxygenation indices, dynamic pulmonary compliance and pulmonary vascular resistance from baseline to 12, 24 and 48 h following treatment
Secondary	measures of efficiency of ventilation and oxygenation at 12, 24 and 48 h following treatment
Secondary	duration of mechanical ventilation, defined as the cumulative time of mechanical ventilation
Secondary	length of time on CPAP
Secondary	length of time with oxygen supplementation
Secondary	length of time on inotropes and maximum inotropic score.
Secondary	need for and length of use of NO
Secondary	need for and length of use of ECMO
Secondary	time to full enteral feeds
Secondary	attainment of exit criteria
Secondary	development of significant pulmonary hemorrhage
Secondary	development of significant intracranial hemorrhage
Secondary	development of tension pneumothorax requiring drainage
Secondary	need for repeat surfactant
Secondary	length of stay in a level III NICU
Secondary	mortality