Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

NCT00167544 | Completed Phase 2 Results DMC

• 2 other identifiers: K23NS048152HSC-MS-05-0218
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.

Conditions

Bronchopulmonary Dysplasia; Encephalomalacia; Premature Birth

Keywords

Bronchopulmonary Dysplasia; Encephalomalacia; Brain injury; Neurosensory impairment; Corticosteroids; Anti-Inflammatory Agents; Extremely Low Birth Weight (ELBW) infants; Premature Birth; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Total Cerebral Volume as Measured by Volumetric Brain MRI

  Total cerebral volume included all brain gray matter and white matter, including cerebellum.

  38 weeks postmenstrual age (PMA)

Secondary Outcomes (4)

• Regional Brain Volumes

  38-weeks postmenstrual age

• Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure)

  Up to 36 weeks PMA

• Duration of Oxygen Requirement

  Up to 36 weeks PMA

• Survival Without Severe Bronchopulmonary Dysplasia (BPD)

  36 weeks postmenstrual age

Study Arms (2)

1

EXPERIMENTAL

1\. Tapering dose of hydrocortisone every 12 h over 7 day period

Drug: Hydrocortisone

2

PLACEBO COMPARATOR

2\. Identical-appearing saline placebo

Drug: Placebo

Interventions

Hydrocortisone DRUG

Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days

1

Placebo DRUG

Saline

2

Eligibility Criteria

• Age: 1 Week - 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care unit with a birth weight ≤ 1000 grams.
• Ventilator-dependent between 10 and 21 days of age.
• Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥ 2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if improvement noted in the past 24 hours.

You may not qualify if:

• Prior postnatal steroid treatment.
• Evidence of sepsis or necrotizing enterocolitis.
• Known major congenital anomalies of the cardiopulmonary or central nervous system.
• Infants being treated with indomethacin or those likely to require treatment in the next 7 days as judged by the treating physician.
• Inability or unwillingness of parent or legal guardian/representative to give written informed consent.
• Gestational age \< 23 weeks.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 432025, United States

Location

Related Publications (4)

• Parikh NA, Lasky RE, Kennedy KA, Moya FR, Hochhauser L, Romo S, Tyson JE. Postnatal dexamethasone therapy and cerebral tissue volumes in extremely low birth weight infants. Pediatrics. 2007 Feb;119(2):265-72. doi: 10.1542/peds.2006-1354.

  PMID: 17272615 BACKGROUND

• Yu X, Zhang Y, Lasky RE, Datta S, Parikh NA, Narayana PA. Comprehensive brain MRI segmentation in high risk preterm newborns. PLoS One. 2010 Nov 8;5(11):e13874. doi: 10.1371/journal.pone.0013874.

  PMID: 21079730 BACKGROUND

• Parikh NA, Kennedy KA, Lasky RE, McDavid GE, Tyson JE. Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes. J Pediatr. 2013 Apr;162(4):685-690.e1. doi: 10.1016/j.jpeds.2012.09.054. Epub 2012 Nov 8.

  PMID: 23140612 RESULT

• Parikh NA, Kennedy KA, Lasky RE, Tyson JE. Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone. PLoS One. 2015 Sep 16;10(9):e0137051. doi: 10.1371/journal.pone.0137051. eCollection 2015.

  PMID: 26376074 DERIVED

Related Links

• Patient information page - Bronchopulmonary Dysplasia

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Encephalomalacia; Premature Birth; Brain Injuries

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Dr. Nehal Parikh
• Organization: Nationwide Children's Hospital Clinical Research Institute

nehal.parikh@nationwidechildrens.org

614-355-6657

Study Officials

• Nehal A. Parikh, D.O., M.S.

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2012
• Last Updated: August 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-07

Locations

US (1)