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High-Dose DHA for Bronchopulmonary Dysplasia
N/A
Waitlist Available
Led By Pascal M. Lavoie, MD, PhD
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intervention involving enteral administration of high-dose DHA supplementation during the neonatal period
High-dose DHA supplementation defined as direct enteral DHA supplementation at a dose of at least 40 mg/kg/day or DHA supplementation of breast milk or formula aiming for at least 0.4% of total fatty acids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 weeks' pma
Summary
This trial studies if high-dose DHA can reduce the risk of severe BPD in preterm babies born <29 weeks. It'll look at sex, age, weight and delivery method too.
Who is the study for?
This trial is for very preterm infants born at less than 29 weeks of gestation. It includes those in registered clinical trials with data allowing for BPD severity classification at 36 weeks' PMA, and who are receiving high-dose DHA or a control treatment. Infants from trials after 2010 with modern respiratory care practices qualify, but not if the study involves intravenous DHA or combined interventions.
What is being tested?
The study tests if high-dose DHA given through feeding (enteral) reduces severe bronchopulmonary dysplasia risk in very preterm infants compared to a control group with no or low-dose DHA. The effect will be analyzed overall and in subgroups based on sex, age, size at birth, and delivery method.
What are the potential side effects?
As this trial focuses on nutritional supplementation (DHA), specific side effects aren't detailed here; however, typical concerns may include digestive issues or allergic reactions to the supplement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn is receiving high-dose DHA through feeding.
Select...
I am taking a high dose of DHA, at least 40 mg/kg/day or my milk/formula is supplemented to have 0.4% DHA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 weeks' pma
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks' pma
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Severe BPD
Secondary study objectives
"Grade 2- or 3-BPD or death"
Mortality
Severity grades of BPD
Other study objectives
Child's head circumference
Child's length
Child's weight
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: High-dose DHAExperimental Treatment1 Intervention
Enteral supplementation with high-dose DHA in the neonatal period.
Group II: ControlPlacebo Group1 Intervention
Control.
Find a Location
Who is running the clinical trial?
South Australian Health and Medical Research InstituteOTHER
13 Previous Clinical Trials
5,024 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
470 Previous Clinical Trials
165,160 Total Patients Enrolled
CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
107,804 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
800 Patients Enrolled for Bronchopulmonary Dysplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The trial must have collected data to classify the severity of bronchopulmonary dysplasia (BPD) according to Jensen's criteria when the infants are 36 weeks old.My baby was born before 29 weeks of pregnancy.My newborn is receiving high-dose DHA through feeding.Studies testing more than one treatment at the same time, like combining DHA with other nutrients or fatty acids.The study is for babies born after 2010 who are getting modern respiratory care like Jensen's group.I am taking a high dose of DHA, at least 40 mg/kg/day or my milk/formula is supplemented to have 0.4% DHA.I am assigned to receive either a high-dose DHA supplement or a control with little to no DHA.I am considering a trial that involves DHA treatments through an IV.You have already been part of a study that looked at this treatment in a detailed way.The trial is designed so that participants and researchers don't know who is receiving the treatment or the placebo until after the study is done.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: High-dose DHA
Awards:
This trial has 0 awards, including: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.
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