Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-004814 | Other Grant/Funding Number | FDA | |
| 1K24AT009893-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.
The purpose of this study is to determine the effects of IV L-arginine hydrochloride therapy in children with sickle cell disease (SCD) and vaso-occlusive pain events (VOE). Specifically, the impact on total opioid use (mg/kg) over the duration of their emergency department (ED) visit and hospital stay will be evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Arginine | Experimental | Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
|
| Loading Dose and L-Arginine | Experimental | Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine | Drug | L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Parenteral Opioid Use in IV Morphine Equivalents | The total amount of parenteral opioids used by participants measured in mg/kg of IV morphine equivalents. The total is calculated after study drug delivery for participants in the emergency department (ED) and during hospital stay. | Post study drug delivery to discharge from the hospital (Up to 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | The total number of hours spent in the hospital from study drug delivery to time of discharge. | Discharge (Up to 8 days) |
| Time to Vaso-occlusive Pain Event (VOE) Resolution in Emergency Department |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudia Morris, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta at Hugh Spalding | Atlanta | Georgia | 30303 | United States | ||
| Children's Healthcare of Atlanta at Egleston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36322873 | Background | Bakshi N, Liu Z, Gillespie S, Keesari R, Leake D, Khemani K, Kumari P, Rees CA, Dampier C, Morris CR. Patient-reported outcomes in children with sickle cell disease at presentation for an acute pain episode. Blood Adv. 2023 Sep 12;7(17):5103-5107. doi: 10.1182/bloodadvances.2021006794. No abstract available. | |
| 34724240 | Result | Reyes LZ, Figueroa J, Leake D, Khemani K, Kumari P, Bakshi N, Lane PA, Dampier C, Morris CR. Safety of intravenous arginine therapy in children with sickle cell disease hospitalized for vaso-occlusive pain: A randomized placebo-controlled trial in progress. Am J Hematol. 2022 Jan 1;97(1):E21-E24. doi: 10.1002/ajh.26396. Epub 2021 Nov 12. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. |
| FG001 | Loading Dose and L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg |
| FG002 | Placebo | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. |
| 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 | Total Parenteral Opioid Use in IV Morphine Equivalents | The total amount of parenteral opioids used by participants measured in mg/kg of IV morphine equivalents. The total is calculated after study drug delivery for participants in the emergency department (ED) and during hospital stay. | Posted | Mean | Standard Deviation | mg/Kg | Post study drug delivery to discharge from the hospital (Up to 8 days) |
|
Information on adverse events will be assessed from the time study participation begins through the end of study follow up (up to 30 days, or after 21 doses or until discharge, whichever comes first).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of L-arginine (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-admission: Acute Chest Syndrome | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Chest Syndrome after randomization | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Morris | Emory University | 404-727-5500 | claudia.r.morris@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2020 | Sep 24, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2020 | Sep 21, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| L-arginine Loading Dose | Drug | One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg |
|
|
| Placebo | Other | Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. |
|
The total number of hours between study drug delivery and the last parenteral opioid.
| Post study drug delivery (Up to 8 hours) |
| Time to Vaso-occlusive Pain Event (VOE) Resolution in Hospital | The total number of hours between study drug delivery and time of last parenteral opioid use, pain relief improved to tolerate oral pain medications | Post study drug delivery until discharge (up to 8 days) |
| Change in Vaso-occlusive Pain (VOE) Scores | Pain associated with VOE will be measured on a scale of 0-10, by asking subjects to rate their pain level on a subjective scale from 0 to 10, with the ends representing the extreme limits of "no-pain" (0) and "worst pain" (10). | Baseline, Time of discharge (Up to 8 days) |
| Length of Emergency Department (ED) Stay | Total hours from time of ED triage to ED discharge or hospital admission. | Until discharge or Hospital Admission (Up to 24 hours) |
| Rate of Emergency Department (ED) Discharge | Number of participants discharged from ED without a hospital ward admission. | Post emergency department admission (Up to 24 hours) |
| Total Opioid Dose (ORAL + Parenteral) in mg/kg IV Morphine Equivalents | Total opioid dose (ORAL + Parenteral) in mg/kg IV morphine equivalents after study drug delivery up to hospital discharge (up to 8 days) | Post study drug delivery up to hospital discharge (Up to 8 days) |
| Total Number of Study Drug Doses | The total number of study drug doses given throughout the study period. | Duration of study (Up to 8 days) |
| Rate of Acute Chest Syndrome | Number of participants who develop acute chest syndrome (not diagnosed prior to study drug delivery) throughout the study period. | Duration of study (Up to 8 days) |
| Rate of Blood Transfusion | Number of participants requiring a blood transfusion throughout the study period. | Duration of study (Up to 8 days) |
| Oxygen Saturation Level | Average oxygen saturation level of participants at time of ED arrival | At time of Emergency Department Admission |
| Oxygen Saturation Level | The difference in oxygen saturation levels from emergency department arrival to hospital discharge. | At time of hospital admission and at time of Hospital discharge (Up to 8 days) |
| Rate of Return Visits to Emergency Department (ED) Within 72 Hours | Number of ED visits from patients who have been discharged within the previous 72 hours. | Post hospital discharge (within 72 hours) |
| Rate of Hospital Re-admissions Within 72 Hours | Number of patients readmitted to the hospital within 72 hours of discharge. | Post hospital discharge (within 72 hours) |
| Rate of Return Visits to Emergency Department (ED) Within 30 Days | Number of ED visits from patients who have been discharged within the previous 30 days. | Post hospital discharge (within 30 days) |
| Rate of Hospital Re-admissions With 30 Days | Number of patients readmitted to the hospital within 30 days of discharge. | Post hospital discharge (within 30 days) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | United States |
| 40270092 | Derived | Morris CR, Hatabah D, Korman R, Gillespie S, Bakshi N, Brown LA, Harris F, Leake D, Rees CA, Khemani K, Vichinsky EP, Locke A, Wynn B, Griffiths MA, Wilkinson H, Kumari P, Sudmeier L, Shiva S, Dampier CD. Arginine Therapy for Pain in Sickle Cell Disease: A Phase-2 Randomized, Placebo-Controlled Trial. Am J Hematol. 2025 Jul;100(7):1119-1131. doi: 10.1002/ajh.27692. Epub 2025 Apr 24. |
| 32384147 | Derived | Morris CR, Brown LAS, Reynolds M, Dampier CD, Lane PA, Watt A, Kumari P, Harris F, Manoranjithan S, Mendis RD, Figueroa J, Shiva S. Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain. Blood. 2020 Sep 17;136(12):1402-1406. doi: 10.1182/blood.2019003672. |
| BG001 | Loading Dose and L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg |
| BG002 | Placebo | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg |
| OG002 | Placebo | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. |
|
|
| Secondary | Length of Hospital Stay | The total number of hours spent in the hospital from study drug delivery to time of discharge. | Posted | Mean | Standard Deviation | hours | Discharge (Up to 8 days) |
|
|
|
| Secondary | Time to Vaso-occlusive Pain Event (VOE) Resolution in Emergency Department | The total number of hours between study drug delivery and the last parenteral opioid. | Time to vaso-occlusive pain event (VOE) resolution in emergency department could not be determined as none of the participants had pain resolution in the Emergency department and were hospitalized | Posted | Mean | Standard Deviation | hours | Post study drug delivery (Up to 8 hours) |
|
|
|
| Secondary | Time to Vaso-occlusive Pain Event (VOE) Resolution in Hospital | The total number of hours between study drug delivery and time of last parenteral opioid use, pain relief improved to tolerate oral pain medications | Posted | Mean | Standard Deviation | hours | Post study drug delivery until discharge (up to 8 days) |
|
|
|
| Secondary | Change in Vaso-occlusive Pain (VOE) Scores | Pain associated with VOE will be measured on a scale of 0-10, by asking subjects to rate their pain level on a subjective scale from 0 to 10, with the ends representing the extreme limits of "no-pain" (0) and "worst pain" (10). | Posted | Mean | Standard Deviation | score on a scale | Baseline, Time of discharge (Up to 8 days) |
|
|
|
| Secondary | Length of Emergency Department (ED) Stay | Total hours from time of ED triage to ED discharge or hospital admission. | Posted | Mean | Standard Deviation | hours | Until discharge or Hospital Admission (Up to 24 hours) |
|
|
|
| Secondary | Rate of Emergency Department (ED) Discharge | Number of participants discharged from ED without a hospital ward admission. | All patients were admitted to the hospital, none was discharged during Emergency Department stay. | Posted | Count of Participants | Participants | Post emergency department admission (Up to 24 hours) |
|
|
|
| Secondary | Total Opioid Dose (ORAL + Parenteral) in mg/kg IV Morphine Equivalents | Total opioid dose (ORAL + Parenteral) in mg/kg IV morphine equivalents after study drug delivery up to hospital discharge (up to 8 days) | Posted | Mean | Standard Deviation | mg/Kg | Post study drug delivery up to hospital discharge (Up to 8 days) |
|
|
|
| Secondary | Total Number of Study Drug Doses | The total number of study drug doses given throughout the study period. | Posted | Number | doses | Duration of study (Up to 8 days) |
|
|
|
| Secondary | Rate of Acute Chest Syndrome | Number of participants who develop acute chest syndrome (not diagnosed prior to study drug delivery) throughout the study period. | Posted | Count of Participants | Participants | Duration of study (Up to 8 days) |
|
|
|
| Secondary | Rate of Blood Transfusion | Number of participants requiring a blood transfusion throughout the study period. | Posted | Count of Participants | Participants | Duration of study (Up to 8 days) |
|
|
|
| Secondary | Oxygen Saturation Level | Average oxygen saturation level of participants at time of ED arrival | Posted | Mean | Standard Deviation | percentage of oxygenated hemoglobin | At time of Emergency Department Admission |
|
|
|
| Secondary | Oxygen Saturation Level | The difference in oxygen saturation levels from emergency department arrival to hospital discharge. | Posted | Mean | Standard Deviation | percentage of oxygenated hemoglobin | At time of hospital admission and at time of Hospital discharge (Up to 8 days) |
|
|
|
| Secondary | Rate of Return Visits to Emergency Department (ED) Within 72 Hours | Number of ED visits from patients who have been discharged within the previous 72 hours. | Posted | Count of Participants | Participants | Post hospital discharge (within 72 hours) |
|
|
|
| Secondary | Rate of Hospital Re-admissions Within 72 Hours | Number of patients readmitted to the hospital within 72 hours of discharge. | Posted | Count of Participants | Participants | Post hospital discharge (within 72 hours) |
|
|
|
| Secondary | Rate of Return Visits to Emergency Department (ED) Within 30 Days | Number of ED visits from patients who have been discharged within the previous 30 days. | Posted | Count of Participants | Participants | Post hospital discharge (within 30 days) |
|
|
|
| Secondary | Rate of Hospital Re-admissions With 30 Days | Number of patients readmitted to the hospital within 30 days of discharge. | Posted | Count of Participants | Participants | Post hospital discharge (within 30 days) |
|
|
|
| 0 |
| 36 |
| 4 |
| 36 |
| 30 |
| 36 |
| EG001 | Loading Dose and L-Arginine | Participants will be randomized to receive an intravenous (IV) infusion of one-time loading dose of L-arginine (200 mg/kg) followed by standard dose (100 mg/kg) three times a day until time of discharge from the emergency department (ED) or hospital. L-arginine: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital. L-arginine Loading Dose: One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg | 0 | 36 | 9 | 36 | 31 | 36 |
| EG002 | Placebo | Participants will be randomized to receive an intravenous (IV) infusion of placebo (normal saline 1-2 ml/kg) three times a day until time of discharge from the emergency department (ED) or hospital. Placebo: Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital. | 0 | 36 | 6 | 36 | 30 | 36 |
| Re-admission: Vaso-Occlusive Pain Event | Vascular disorders | Systematic Assessment |
|
| Re-admission: Non sickle Cell event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Prolonged hospitalization: Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
|
| Prolonged hospitalization: Priapism | Renal and urinary disorders | Systematic Assessment |
|
| Acute Chest Syndrome | Cardiac disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oxygen administered | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Headache after randomization | Nervous system disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting after randomization | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Leg/ Neck/ Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Splenic Sequestration | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lip Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Transfusion | Blood and lymphatic system disorders | Systematic Assessment |
|
| Emergency Department visit after Discharge | General disorders | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated ALT | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated AST | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Bilirrubin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Alkaline Phosphatase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated creatinine | Blood and lymphatic system disorders | Systematic Assessment |
|
| Decreased Neutrophil count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia/ Decreased Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hyperglycemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Decreased Platelet count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Decreased Bicarbonate | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000601 | Amino Acids, Essential |
|
| Hospital Discharge Minus ED Arrival |
|
|