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Surfactant

Surfactant Treatments for Meconium Aspiration Syndrome

Phase 3
Waitlist Available
Led By Patrick McNamara, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants ≥ 36 weeks gestational age with evidence of meconium aspiration syndrome
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare the effects of two different surfactant treatments for meconium aspiration syndrome.

Who is the study for?
This trial is for newborns at least 36 weeks old with meconium aspiration syndrome needing respiratory support within 6 hours of birth. They must be enrolled within a day of birth and have significant oxygenation difficulty, indicated by an OI > 15. Babies with likely intensive care withdrawal, hemodynamic instability on multiple inotropes, major congenital anomalies, certain heart diseases, prior surfactant use, severe pulmonary or brain hemorrhage can't participate.Check my eligibility
What is being tested?
The study compares two treatments for babies with meconium aspiration: surfactant lavage versus bolus surfactant administration. It aims to see if lavage leads to faster improvement in lung function and shorter time on mechanical breathing support. This pilot will help decide if a larger trial is feasible and safe.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surfactant therapy such as airway obstruction or changes in blood pressure and heart rate; the safety profile will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born at or after 36 weeks and has meconium aspiration syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% change in dynamic pulmonary compliance from baseline to 1 and 6 h following treatment
% change in oxygenation indices from baseline to 1 and 6 h following treatment
% change in pulmonary artery pressure from baseline to 1 and 6 h following treatment
+2 more
Secondary outcome measures
% change in oxygenation indices, dynamic pulmonary compliance and pulmonary vascular resistance from baseline to 12, 24 and 48 h following treatment
attainment of exit criteria
development of significant intracranial hemorrhage
+13 more

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
685 Previous Clinical Trials
6,944,723 Total Patients Enrolled
Patrick McNamara, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Bolus Surfactant (Surfactant) Clinical Trial Eligibility Overview. Trial Name: NCT00312507 — Phase 3
Meconium Aspiration Syndrome Clinical Trial 2023: Bolus Surfactant Highlights & Side Effects. Trial Name: NCT00312507 — Phase 3
Bolus Surfactant (Surfactant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00312507 — Phase 3
Meconium Aspiration Syndrome Research Study Groups:

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction this medication?

"The safety of this proposed treatment was given a score of 3 by our Power team. A Phase 3 trial rating suggests that, while there is data affirming the efficacy of the medication, multiple rounds have also supported its safety."

Answered by AI

Are there any current vacancies for participants in this research?

"No, this specific trial is not recruiting patients at the moment. However, there are two other trials that have open enrollment periods right now. This particular study was first posted on April 1st 2006 and received its last edit on October 16th of the same year."

Answered by AI

How can I get involved in this research?

"Up to 20 neonates that currently have meconium aspiration syndrome and are between 1 hour and 24 hours old can participate in this trial. Additionally, these infants must also satisfy the following requirements: an oxygenation index (OI) above 15 ((FiO2 x MAP) / PaO2), where MAP is mean airway pressure, as well as having difficulty maintaining oxygen saturation levels and being intubated with an arterial line for monitoring purposes."

Answered by AI

Will this experiment be testing the effects of the medication on patients over 50 years old?

"The age limit to participate in this trial is set at 24 hours old, with a minimum age requirement of 1 hour."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
2006. "Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00312507.
~1 spots leftby Apr 2025
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