Recruiting
Phase 3

Surfactant Lavage vs. Bolus Surfactant

Sponsor:

The Hospital for Sick Children

Code:

NCT00312507

Conditions

Meconium Aspiration Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Bovine Lipid Extract Surfactant (administered by lavage)

Bovine Lipid Extract Surfactant (administered by bolus)

Study Details

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

Study ID

NCT00312507

Start date

Apr, 2006

Status verified date

Oct, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Bovine Lipid Extract Surfactant (administered by lavage)

Bovine Lipid Extract Surfactant (administered by bolus)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Patrick McNamara, MD

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

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Patrick McNamara, MD

416 813 5773patrick.mcnamara@sickkids.ca

Principal Investigator:

Patrick McNamara, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Oct 17, 2006

Last verified

Oct, 2006

Keywords

  • Meconium Aspiration Syndrome
  • Surfactant
  • Bronchoalveolar Lavage
  • newborns

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2006-10-17.