Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
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ClinicalTrials.gov Identifier: NCT01579513 |
Recruitment Status :
Completed
First Posted : April 18, 2012
Results First Posted : June 18, 2019
Last Update Posted : December 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Congenital Heart Disease Disorder of Fetus or Newborn | Drug: Methylprednisolone Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 190 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | May 25, 2018 |
Actual Study Completion Date : | December 19, 2018 |

Arm | Intervention/treatment |
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Active Comparator: Intraoperative Methylprednisone
Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.
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Drug: Methylprednisolone
Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.
Other Names:
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Placebo Comparator: Placebo
Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.
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Drug: Placebo
Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.
Other Name: Normal Saline |
- Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population.
- Duration of Mechanical Ventilation Post Cardiac Surgery. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]Amount of time on mechanical ventilation following cardiac surgery
- Intensive Care Unit Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]Amount of time in the intensive care unit following cardiac surgery
- Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]Total duration of hospital stay following cardiac surgery
- Neurodevelopmental Outcome [ Time Frame: 1 year ]Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154.

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Ages Eligible for Study: | up to 30 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age < 1 month
- Male and female patients who are scheduled to undergo cardiac surgery involving CPB
Exclusion Criteria:
- Prematurity: < 37 weeks post gestational age at time of surgery
- Treatment with intravenous steroids within the two days prior to scheduled surgery.
- Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization.
- Suspected infection that would contraindicate steroid use (eg - Herpes)
- Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (eg - gastrointestinal bleeding).
- Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579513
United States, Georgia | |
Children's Healthcare of Atlanta/Emory University | |
Atlanta, Georgia, United States, 30233 | |
United States, South Carolina | |
Medical University of South Carolina, Pediatric Cardiology | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Eric M Graham, MD | Medical University of South Carolina |
Documents provided by Medical University of South Carolina:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT01579513 |
Other Study ID Numbers: |
Pro16545 R01HL112968 ( U.S. NIH Grant/Contract ) |
First Posted: | April 18, 2012 Key Record Dates |
Results First Posted: | June 18, 2019 |
Last Update Posted: | December 9, 2019 |
Last Verified: | November 2019 |
Cardiopulmonary Bypass (CPB) System Inflammatory Response inflammation Methylprednisolone Neonates Steroid Cardiac Surgical Procedures Children Infants Pediatrics |
Glucocorticoid Heart Disease Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Corticosteroid methylprednisolone Hemisuccinate Hormones Physiological Effects of Drugs Randomized Clinical Trial |
Fetal Diseases Heart Diseases Cardiovascular Diseases Pregnancy Complications Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Glucocorticoids |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |