Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

NCT00312507 | Unknown Phase 3

• 1 other identifier: 1000007730
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Meconium Aspiration Syndrome

Keywords

Meconium Aspiration Syndrome; Surfactant; Bronchoalveolar Lavage; newborns

Outcome Measures

Primary Outcomes (5)

• % 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 Outcomes (16)

• % 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

Interventions

Bovine Lipid Extract Surfactant (administered by lavage) DRUG

Bovine Lipid Extract Surfactant (administered by bolus) DRUG

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Patrick McNamara, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick McNamara, MD

CONTACT

416-813-5773; patrick.mcnamara@sickkids.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2006
• First Posted: April 10, 2006
• Study Start: April 1, 2006
• Last Updated: October 17, 2006

Record last verified: 2006-10

Locations

CA (1)