Hydrocortisone for Bronchopulmonary Dysplasia

Recruiting at 19 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: NICHD Neonatal Research Network

Must not be taking: Indomethacin, Ibuprofen, Corticosteroids

Disqualifiers: Major congenital anomalies, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Research Team

Uday Devaskar, MD

Principal Investigator

University of California, Los Angeles

Pablo J Sanchez, MD

Principal Investigator

Research Institute at Nationwide Children's Hospital

Bradley Yoder, MD

Principal Investigator

University of Utah

C. Michael Cotten, MD

Principal Investigator

Duke University

David Carlton, MD

Principal Investigator

Emory University

Abhik Das, PhD

Principal Investigator

RTI International

Krisa P Van Meurs, MD

Principal Investigator

Stanford University

Edward F Bell, MD

Principal Investigator

University of Iowa

Kristi L Watterberg, MD

Principal Investigator

University of New Mexico

Jon E Tyson, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Carl T D'Angio, MD

Principal Investigator

University of Rochester

Greg Sokol, MD

Principal Investigator

Indiana University

Brenda P Poindexter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Abbot R Laptook, MD

Principal Investigator

Brown University, Women & Infants Hospital of Rhode Island

William Truog, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Eric Eichenwald, MD

Principal Investigator

University of Pennsylvania

Michele C Walsh, MD

Principal Investigator

Case Western Reserve University, Rainbow Babies and Children's Hospital

Waldemar A Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Seetha Shankaran, MD

Principal Investigator

Wayne State University

Myra Wyckoff, MD

Principal Investigator

University of Texas, Southwestern Medical Center at Dallas

Eligibility Criteria

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.

Inclusion Criteria

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

My baby was born before 30 weeks of pregnancy.

You are using a tube to help you breathe.

Exclusion Criteria

You were born with major physical abnormalities.

Choosing to limit assistance or help.

I have taken hydrocortisone in the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A 10-day tapering course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age

10 days

Follow-up

Participants are monitored for survival without moderate/severe BPD and neurodevelopmental outcomes at 22-26 months corrected age

22-26 months

Extended follow-up

Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess functional developmental and respiratory outcomes

5-6 years

Treatment Details

Interventions

• Hydrocortisone
• Placebo

Trial Overview 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.

Participant Groups

Group I: Hydrocortisone Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Saline placebo

Hydrocortisone is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

Approved in United States as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

Approved in Canada as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+