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Corticosteroid
Hydrocortisone for Bronchopulmonary Dysplasia
Phase 3
Waitlist Available
Led By Pablo J Sanchez, MD
Research Sponsored by NICHD Neonatal Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
Infants <30 weeks estimated gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth up to one year
Awards & highlights
Study Summary
This trial will test whether a 10-day course of the drug hydrocortisone can improve survival rates and neurodevelopmental outcomes in premature infants who are intubated and on mechanical ventilation.
Who is the study for?
This trial is for newborns who are less than 30 weeks old at gestational age, intubated and have been on mechanical ventilation for at least a week. They must be in the hospital from birth or transferred within 72 hours after birth. Babies with major congenital anomalies, those with life support limitations, prior extensive hydrocortisone use, or recent indomethacin/ibuprofen treatment cannot participate.Check my eligibility
What is being tested?
The study tests if a 10-day course of hydrocortisone can help premature infants avoid bronchopulmonary dysplasia (BPD) and improve survival without severe neurodevelopmental issues by age two. Infants will randomly receive either hydrocortisone or a placebo to compare outcomes.See study design
What are the potential side effects?
Potential side effects of hydrocortisone may include changes in blood pressure, blood sugar levels, increased risk of infections due to weakened immune response, stomach ulcers, and potential impact on growth and development.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was born at or admitted to an NRN site within 72 hours after birth.
Select...
My baby was born before 30 weeks of pregnancy.
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I have been on a ventilator for at least 7 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from birth up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth up to one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)
Secondary outcome measures
Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA)
Days of Mechanical Ventilation up to Status
Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14
+35 moreOther outcome measures
Bayley Scales of Infant Development (BSID) cognitive composite score <70
Bayley Scales of Infant Development (BSID) cognitive composite score <85
Bayley Scales of Infant Development (BSID) motor composite score <70
+19 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydrocortisoneExperimental Treatment1 Intervention
hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents)
Group II: PlaceboPlacebo Group1 Intervention
Saline placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1260
Find a Location
Who is running the clinical trial?
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,216 Total Patients Enrolled
13 Trials studying Bronchopulmonary Dysplasia
8,316 Patients Enrolled for Bronchopulmonary Dysplasia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,305,696 Total Patients Enrolled
22 Trials studying Bronchopulmonary Dysplasia
9,277 Patients Enrolled for Bronchopulmonary Dysplasia
NICHD Neonatal Research NetworkLead Sponsor
59 Previous Clinical Trials
204,970 Total Patients Enrolled
12 Trials studying Bronchopulmonary Dysplasia
11,123 Patients Enrolled for Bronchopulmonary Dysplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born with major physical abnormalities.Choosing to limit assistance or help.I have taken hydrocortisone in the last week.I have been treated with corticosteroids for BPD.I was born at or admitted to an NRN site within 72 hours after birth.I have taken hydrocortisone for at least 14 days.My baby was born before 30 weeks of pregnancy.You are using a tube to help you breathe.I have not taken indomethacin or ibuprofen in the last 48 hours.I have been on a ventilator for at least 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Hydrocortisone
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Do we have any other data on Hydrocortisone's effects?
"The first clinical trial involving hydrocortisone was completed in 1995 at the National Institutes of Health Clinical Centre. Since then, there have been a total of 18,393 completed trials. At the moment, 63 different studies are ongoing with several of them taking place in Columbus, Ohio."
Answered by AI
Are there any North American hospitals not participating in this investigation?
"The trial is currently being conducted by researchers at Nationwide Children's Hospital in Columbus, Ohio, as well as the University of California - Los Angeles and University of Alabama at Birmingham. There are also 20 other active sites."
Answered by AI
Are there any severe side-effects to Hydrocortisone?
"Given that this is a Phase 3 trial with data supporting efficacy as well as multiple rounds of data affirming safety, our team at Power has given Hydrocortisone a score of 3."
Answered by AI
For what sorts of issues is hydrocortisone most often prescribed?
"Hydrocortisone is frequently used to treat ulcerative colitis, but it can also be employed to ameliorate symptoms in patients with conditions such as malignant neoplasms, varicella-zoster virus acute retinal necrosis, and crohn disease."
Answered by AI
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