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Corticosteroid

Hydrocortisone for Bronchopulmonary Dysplasia

Phase 3

Waitlist Available

Led By Uday Devaskar, 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

Must not have

Previous corticosteroid treatment for BPD

Received hydrocortisone for 14 or more cumulative days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth up to one year

Awards & highlights

Pivotal Trial

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.

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.

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 below

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I was born at or admitted to an NRN site within 72 hours after birth.

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My baby was born before 30 weeks of pregnancy.

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I have been on a ventilator for at least 7 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with corticosteroids for BPD.

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I have taken hydrocortisone for at least 14 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)

Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)

Secondary study objectives

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 more

Other study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

~1280

0 / 5Eligibility criteria met