Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00312507

Purpose

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).

Condition	Intervention	Phase
Meconium Aspiration Syndrome	Drug: Bovine Lipid Extract Surfactant (administered by lavage) Drug: Bovine Lipid Extract Surfactant (administered by bolus)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

Resource links provided by NLM:

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

% change in oxygenation indices from baseline to 1 and 6 h following treatment
% change in dynamic pulmonary compliance from baseline to 1 and 6 h following treatment
% change in pulmonary artery pressure from baseline to 1 and 6 h following treatment
measures of efficacy of ventilation and oxygenation at 1 h and 6 h following treatment
cardiac function by echocardiography at 6 hours following treatment

Secondary Outcome Measures:

% change in oxygenation indices, dynamic pulmonary compliance and pulmonary vascular resistance from baseline to 12, 24 and 48 h following treatment
measures of efficiency of ventilation and oxygenation at 12, 24 and 48 h following treatment
duration of mechanical ventilation, defined as the cumulative time of mechanical ventilation
length of time on CPAP
length of time with oxygen supplementation
length of time on inotropes and maximum inotropic score.
need for and length of use of NO
need for and length of use of ECMO
time to full enteral feeds
attainment of exit criteria
development of significant pulmonary hemorrhage
development of significant intracranial hemorrhage
development of tension pneumothorax requiring drainage
need for repeat surfactant
length of stay in a level III NICU
mortality

Estimated Enrollment:	20
Study Start Date:	April 2006

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, 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.

Eligibility

Ages Eligible for Study:	up to 24 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312507

Contacts

Contact: Patrick McNamara, MD

416-813-5773

patrick.mcnamara@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Patrick McNamara, MD 416 813 5773 patrick.mcnamara@sickkids.ca
Principal Investigator: Patrick McNamara, MD
Sub-Investigator: Simone Vaz, MD
Sub-Investigator: Hilary Whyte, MD
Sub-Investigator: Jaques Belik, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Patrick McNamara, MD

The Hospital for Sick Children

More Information

No publications provided

Study ID Numbers:	1000007730
Study First Received:	April 6, 2006
Last Updated:	October 16, 2006
ClinicalTrials.gov Identifier:	NCT00312507 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Meconium Aspiration Syndrome
Surfactant
Bronchoalveolar Lavage
newborns

Additional relevant MeSH terms:

Respiratory System Agents
Meconium Aspiration Syndrome
Pregnancy Complications
Disease
Respiration Disorders
Pharmacologic Actions
Fetal Diseases

Pathologic Processes
Respiratory Tract Diseases
Syndrome
Lung Diseases
Therapeutic Uses
Infant, Newborn, Diseases
Pulmonary Surfactants

ClinicalTrials.gov processed this record on February 04, 2010