Trial Outcomes & Findings for Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass (NCT NCT01579513)
NCT ID: NCT01579513
Last Updated: 2019-12-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Primary Hospitalization
STARTED
|
91
|
99
|
|
Primary Hospitalization
COMPLETED
|
81
|
95
|
|
Primary Hospitalization
NOT COMPLETED
|
10
|
4
|
|
1 Year Neurodevelopmental Follow up
STARTED
|
81
|
95
|
|
1 Year Neurodevelopmental Follow up
COMPLETED
|
61
|
68
|
|
1 Year Neurodevelopmental Follow up
NOT COMPLETED
|
20
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Baseline characteristics by cohort
| Measure |
Intraoperative Methylprednisone
n=81 Participants
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.
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.
|
Placebo
n=95 Participants
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.
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.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 days
STANDARD_DEVIATION 5.4 • n=5 Participants
|
8.2 days
STANDARD_DEVIATION 5.6 • n=7 Participants
|
8.6 days
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
95 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Weight at surgery
|
3.2 Kg
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.4 Kg
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.3 Kg
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeksThe 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.
Outcome measures
| Measure |
Intraoperative Methylprednisone
n=81 Participants
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.
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.
|
Placebo
n=95 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
|
27 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeksAmount of time on mechanical ventilation following cardiac surgery
Outcome measures
| Measure |
Intraoperative Methylprednisone
n=81 Participants
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.
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.
|
Placebo
n=95 Participants
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.
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.
|
|---|---|---|
|
Duration of Mechanical Ventilation Post Cardiac Surgery.
|
4 Days
Interval 3.0 to 7.0
|
5 Days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeksAmount of time in the intensive care unit following cardiac surgery
Outcome measures
| Measure |
Intraoperative Methylprednisone
n=81 Participants
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.
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.
|
Placebo
n=95 Participants
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.
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.
|
|---|---|---|
|
Intensive Care Unit Stay
|
11 Days
Interval 7.0 to 18.0
|
11 Days
Interval 7.0 to 20.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeksTotal duration of hospital stay following cardiac surgery
Outcome measures
| Measure |
Intraoperative Methylprednisone
n=81 Participants
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.
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.
|
Placebo
n=95 Participants
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.
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.
|
|---|---|---|
|
Hospital Stay
|
20 Days
Interval 13.0 to 35.0
|
22 Days
Interval 12.0 to 35.0
|
SECONDARY outcome
Timeframe: 1 yearBayley 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.
Outcome measures
| Measure |
Intraoperative Methylprednisone
n=61 Participants
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.
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.
|
Placebo
n=68 Participants
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.
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.
|
|---|---|---|
|
Neurodevelopmental Outcome
Cognitive Domain
|
105 score on a scale
Standard Deviation 15
|
104 score on a scale
Standard Deviation 14
|
|
Neurodevelopmental Outcome
Language Domain
|
101 score on a scale
Standard Deviation 15
|
100 score on a scale
Standard Deviation 13
|
|
Neurodevelopmental Outcome
Motor Domain
|
90 score on a scale
Standard Deviation 16
|
91 score on a scale
Standard Deviation 19
|
Adverse Events
Intraoperative Methylprednisone
Serious events: 4 serious events
Other events: 2 other events
Deaths: 5 deaths
Placebo
Serious events: 11 serious events
Other events: 2 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Intraoperative Methylprednisone
n=81 participants at risk
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.
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.
|
Placebo
n=95 participants at risk
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.
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.
|
|---|---|---|
|
Cardiac disorders
Extracorporeal membrane oxygenation
|
4.9%
4/81 • For the entirety of the initial neonatal hospitalization, an expected average of up to 5 weeks
Death or the use of extracorporeal membrane oxygenation
|
11.6%
11/95 • For the entirety of the initial neonatal hospitalization, an expected average of up to 5 weeks
Death or the use of extracorporeal membrane oxygenation
|
Other adverse events
| Measure |
Intraoperative Methylprednisone
n=81 participants at risk
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.
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.
|
Placebo
n=95 participants at risk
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.
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.
|
|---|---|---|
|
Endocrine disorders
Insulin therapy
|
2.5%
2/81 • For the entirety of the initial neonatal hospitalization, an expected average of up to 5 weeks
Death or the use of extracorporeal membrane oxygenation
|
2.1%
2/95 • For the entirety of the initial neonatal hospitalization, an expected average of up to 5 weeks
Death or the use of extracorporeal membrane oxygenation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place