Meconium Aspiration SyndromePhase 3NCT00312507
Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
A Phase 3 study testing Bovine Lipid Extract Surfactant (administered by lavage) and Bovine Lipid Extract Surfactant (administered by bolus) in people with Meconium Aspiration Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Bovine Lipid Extract Surfactant (administered by lavage) and Bovine Lipid Extract Surfactant (administered by bolus)
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Patrick McNamara, MD, 416 813 5773, patrick.mcnamara@sickkids.ca
Patrick McNamara, MD
About this study
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).
Read the 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.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Bovine Lipid Extract Surfactant (administered by lavage), Bovine Lipid Extract Surfactant (administered by bolus)
- Keywords
- Meconium Aspiration Syndrome, Surfactant, Bronchoalveolar Lavage, newborns
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Lipid Extract Surfactant (administered by lavage)Drug
Bovine Lipid Extract Surfactant (administered by bolus)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration SyndromeStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Investigators
- Patrick McNamara, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312507
- Sponsor's protocol ID
- 1000007730
- Status last verified
- Oct 2006
- First submitted
- 6 Apr 2006
- Last updated
- 17 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
- ClinicalTrials.gov ID
- NCT00312507
- Acronym / sponsor ID
- 1000007730
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- Meconium Aspiration Syndrome, Surfactant, Bronchoalveolar Lavage, newborns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2006
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Lipid Extract Surfactant (administered by lavage) | Drug | – |
| Bovine Lipid Extract Surfactant (administered by bolus) | Drug | – |
Primary outcome
% 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
16 secondary outcomes
% 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2006.
Related trials for Meconium Aspiration Syndrome
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick McNamara, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bovine Lipid Extract Surfactant (administered by lavage) and Bovine Lipid Extract Surfactant (administered by bolus) in people with Meconium Aspiration Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick McNamara, MD (416-813-5773, patrick.mcnamara@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% change in oxygenation indices from baseline to 1 and 6 h following treatment. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2006.