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low enrollment
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is no specific therapy for NEC that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. Therefore, we propose to examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrocortisone | Experimental | Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
|
| Placebo | Placebo Comparator | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone | Drug | Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via IV route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| Measure | Description | Time Frame |
|---|---|---|
| CRP Level | C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC. | 3 days |
| CRP Level | C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age) | GI failure | 36 weeks corrected gestational age |
| Spontaneous Intestinal Perforation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandy L Frost, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comer Childrens Hospital | Chicago | Illinois | United States | |||
| NorthShore University HealthSystem |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrocortisone | hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| FG001 | Placebo | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
premature neonates
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrocortisone | Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CRP Level | C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC. | This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug. | Posted | Number | mg/L | 3 days |
|
3 months
This study was terminated due to low enrollment. The one enrolled infant was later thought not to have NEC. There was no data to analyze.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrocortisone | Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
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This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brandy Frost | NorthShore University HealthSystem | 847-570-2033 | bfrost@northshore.org |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| placebo | Drug | Subjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
|
Whether or not infants had perforation.
| at 36 weeks corrected gestational age |
| Need for Gastrointestinal Surgery | Whether or not the infants required GI surgery by 36 weeks CGA | at 36 weeks corrected gestational age |
| Incidence of Sepsis | Whether or not enrolled subjects had sepsis before 40 weeks CGA | at 40 weeks corrected gestational age |
| Time on Parenteral Nutrition | Total time on parenteral nutrition | at 40 weeks corrected gestational age |
| Time to Full Enteral Feeds | this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA | at 40 weeks corrected gestational age |
| Length of Stay | this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA. | at 40 weeks corrected gestational age |
| Growth Velocity | Growth velocity after NEC diagnosis, in g/kg/day. | at 40 weeks CGA |
| Mortality | at 40 weeks corrected gestational age |
| Evanston |
| Illinois |
| 60201 |
| United States |
| BG001 | Placebo | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. |
|
|
| Primary | CRP Level | C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC | This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug. | Posted | Number | mg/L | 7 days |
|
|
|
| Secondary | Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age) | GI failure | The one enrolled infant did not have GI failure at 36 weeks CGA. | Posted | Count of Participants | Participants | 36 weeks corrected gestational age |
|
|
|
| Secondary | Spontaneous Intestinal Perforation | Whether or not infants had perforation. | Only 1 infant enrolled (placebo group) | Posted | Count of Participants | Participants | at 36 weeks corrected gestational age |
|
|
|
| Secondary | Need for Gastrointestinal Surgery | Whether or not the infants required GI surgery by 36 weeks CGA | We only enrolled one subject (placebo group) | Posted | Count of Participants | Participants | at 36 weeks corrected gestational age |
|
|
|
| Secondary | Incidence of Sepsis | Whether or not enrolled subjects had sepsis before 40 weeks CGA | We only enrolled one subject (placebo group). She did have fungal sepsis). | Posted | Count of Participants | Participants | at 40 weeks corrected gestational age |
|
|
|
| Secondary | Time on Parenteral Nutrition | Total time on parenteral nutrition | Only one subject was enrolled (placebo group) | Posted | Number | days | at 40 weeks corrected gestational age |
|
|
|
| Secondary | Time to Full Enteral Feeds | this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA | We only enrolled one subject into the placebo group. | Posted | Number | days | at 40 weeks corrected gestational age |
|
|
|
| Secondary | Length of Stay | this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA. | only one subject enrolled into placebo group | Posted | Number | days | at 40 weeks corrected gestational age |
|
|
|
| Secondary | Growth Velocity | Growth velocity after NEC diagnosis, in g/kg/day. | We only enrolled one subject into the placebo group. | Posted | Number | grams/kg/d | at 40 weeks CGA |
|
|
|
| Secondary | Mortality | Only one subject was enrolled into the placebo group. | Posted | Count of Participants | Participants | at 40 weeks corrected gestational age |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn. | 0 | 1 | 0 | 1 |
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| D007410 |
| Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |