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Non-invasive Respiratory Support for Premature Birth (NOVEL Trial)
N/A
Recruiting
Research Sponsored by McMaster Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (total 42 months)
Awards & highlights
NOVEL Trial Summary
This trial is studying two ways to give breathing support to premature babies.
Who is the study for?
This trial is for preterm infants born before 29 weeks, at least 72 hours old, in specific NICUs where families consented to participate. It excludes babies with major airway malformations, genetic abnormalities, or those who've had high-level nasal breathing support for over 4 hours.Check my eligibility
What is being tested?
The study compares two non-invasive respiratory supports for premature babies: 'nasal intermittent positive airway pressure' (NIPPV) which gives artificial breaths through a nose-mask and an increased pressure version of the traditional nasal CPAP.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include irritation or injury to the nose from the mask, stomach bloating, or difficulty transitioning to natural breathing.
NOVEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (total 42 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (total 42 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to enroll a minimum of 10% of all eligible neonates per year at each site
Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations
Fewer than 20% randomized subjects with protocol violations in High CPAP arm
+1 moreSecondary outcome measures
Air leak syndromes (n, defined as pneumothorax, pneumomediastinum, and/or pulmonary interstitial emphysema as defined on radiographic report)
Borderline Personality Disorder
Perfusion (procedure)
+12 moreNOVEL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High NCPAPExperimental Treatment1 Intervention
Administration of high NCPAP (> 8 cmH2O) following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)
Group II: NIPPVActive Control1 Intervention
Administration of NIPPV following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)
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Who is running the clinical trial?
McMaster Children's HospitalLead Sponsor
38 Previous Clinical Trials
17,225 Total Patients Enrolled
Hamilton Academic Health Sciences OrganizationOTHER
20 Previous Clinical Trials
4,766 Total Patients Enrolled
Hamilton Health Sciences Foundation - New Investigator FundUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant birth defect affecting your upper airway, such as a cleft lip or palate, a severe jaw problem, or a blockage in your throat.You are suspected or confirmed to have an abnormality in your chromosomes or genes.Babies born before 29 weeks who are at least 3 days old and admitted to one of three specific hospitals.You have a major birth defect that has not been fixed yet, like a hole in the diaphragm or stomach area, or a connection between the windpipe and the esophagus.Using certain breathing assistance machines for more than 4 hours outside of the study is not allowed.
Research Study Groups:
This trial has the following groups:- Group 1: NIPPV
- Group 2: High NCPAP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results is this research attempting to achieve?
"The objective of this 42-month trial is to recruit at least 10% of the eligible neonates each year from each participating centre. Secondary outcomes include assessments for cerebral and renal regional perfusion, need for endotracheal ventilation over 72 hours and 7 days post randomization, as well as duration (in days) of mechanical ventilator use following randomisation."
Answered by AI
Are there still vacancies available for people to join the trial?
"According to clinicaltrials.gov, this research project is not recruiting participants at the moment. The trial was first posted on May 15th of 2018 and last updated on October 5th of 2020. However, there are currently 477 other trials actively seeking volunteers for participation."
Answered by AI
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