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This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis. The experimental arm (DPR group) will receive adjuvant DPR with standard treatment for gastroschisis (staged silo closure). The control arm (SoC group) will receive standard treatment for gastroschisis without DPR.
The Research Team will prospectively enroll all neonates with the diagnosis of gastroschisis presenting to ACH within 12 hours after birth for whom consent is signed by the parent(s)/legally authorized representative (LAR). The Research Team anticipates enrolling 40 subjects at Arkansas Children's Hospital. All subjects that have their abdominal wall defect closed will be defined as having completed active participation in the study.
Gastroschisis is a clinical condition characterized by a defect in the normal development of the abdominal wall. The defect is present to the right of the umbilicus leading to in utero bowel evisceration and exposure to amniotic fluid. After birth and prior to operation, the usual treatment consists of covering the bowel with an impermeable plastic bag to prevent additional fluid losses and bowel desiccation. Subsequent operative intervention occurs either in the operating room or in the neonatal intensive care unit. Two surgical options include primary closure of the abdomen or placement of a silastic silo followed by subsequent closure several days later as a staged procedure. The main reason the abdominal wall is not closed initially is due to fear of abdominal compartment syndrome, a condition caused by high intra-abdominal pressures leading to respiratory and circulatory compromise. The key points of the initial surgery involve examining the intestine for any signs of atresia, bowel compromise, and either placement of the bowels back into the abdomen or a spring-loaded silo.
Arkansas Children's Hospital (ACH) has one of the highest rates of gastroschisis patients in the country and therefore has extensive experience managing these patients. It is not currently known why ACH has one of the highest rates of gastroschisis, but it has been postulated it may be due to some factor more common in low socioeconomic status population. ACH is the only pediatric hospital in the state of Arkansas. Quarterly, reviews of the Children's Hospital National Database (CHND) are performed to track the institutions progress in comparison to national trends. ACH's current surgical practice is to place nearly all patients in a silastic silo for staged reduction. Rarely are patients with gastroschisis treated with primary surgical closure at ACH. Serial reductions are performed and once the abdominal contents are at the level of the fascia the abdomen is closed in the operating room. Previous data indicates an average of five days from birth for final reduction and closure. After closure, there can be significant intestinal dysmotility with a prolonged ileus and a delayed return of bowel function. Generally, those with uncomplicated gastroschisis spend approximately 26 days in the neonatal intensive care unit before discharge home.
From historical CHND data, it is known that patients with simple gastroschisis have an average length of stay of 29 days, average of 5 days until abdominal wall closure, average of 7 days until start of enteral feeding after abdominal wall closure and average of 10 days until meeting 100 kcal per kg per day enteral feeds.
Direct Peritoneal Resuscitation The University of Louisville has been at the forefront of research for Direct Peritoneal Resuscitation (DPR). This technique uses clinically available peritoneal dialysis solution instilled into the abdomen with an initial bolus of 500 mL followed by a rate of 1.5 mL/kg/h in adults undergoing closure of the abdominal wall after traumatic injuries.
The aforementioned lab has also studied DPR in a rat model of hemorrhagic shock. The model has shown decreased mortality and increased intestinal and liver blood flow [2-5]. The group further investigated the use of DPR in a rat model of Necrotizing Enterocolitis (NEC) and discovered that 1.5% and 2.5% peritoneal dialysis solutions used as DPR improved intestinal blood flow, and with the 1.5% solution, there was less hyperglycemia than in the group treated with the 2.5% solution.
DPR has also been studied in the treatment of severely injured trauma patients and has shown a decrease in days until closure with improved outcomes. A randomized controlled study of 103 subjects requiring damage control surgery, i.e. open abdominal cavities, found that peritoneal resuscitation reduced the time to definitive abdominal closure, reduced intra-abdominal infections and reduced mortality.
Exposure of the abdominal viscera and its placement in a silo puts the neonate in a metabolically stressed state. Using DPR has been shown to counteract the systemic inflammatory response, leading to dilation of arterioles in the intestine resulting in reduced organ ischemia and cellular hypoxia.
Several case series have demonstrated safety of peritoneal dialysis in infants with recent abdominal surgery and intestinal perforation. In pediatric patients, peritoneal resuscitation has been used in two infants with perforated NEC who were too unstable to undergo laparotomy. Both survived and went on to undergo laparotomy.
The patient with gastroschisis is considered as an equivalent to the general surgery patient with the open abdomen and that adjunctive DPR treatment may be able to accelerate abdominal closure and improve outcomes.
It is hypothesized that the DPR group will have a more benign hospital course as measured by time to full enteral feeds of 100 kcal/kg/day. Time to abdominal wall closure, time on TPN, length of hospital stay and intestinal motility post-closure using bedside ultrasounds will also be assessed. Secondly, it is hypothesized that there will be no deleterious effects related to introducing the peritoneal dialysis solution into the silo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SoC) Treatment Group | Active Comparator | The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons. |
|
| Direct Peritoneal Resuscitation (DPR) Treatment Group | Experimental | The DPR group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects will be treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement), which is usually four to five days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SoC Staged Silo Closure | Procedure | Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Full Enteral Feeds | To demonstrate that subjects treated with DPR will have a more benign hospital course as measured by time to full enteral feeds. The primary outcome measure will be time to full feeds of 100 kcal/kg/day. This is assessed once daily on morning rounds by the neonatology team. | Up to Hospital Discharge (average 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Abdominal Wall Closure | Serial reductions are performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. | Up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Primary gastroschisis repair
Vanishing gastroschisis
Encapsulating peritoneal sclerosis
Infants < 2 kg and < 34 weeks gestation
Infants > 12 hours at enrollment
Severe hypotension, defined as either:
Severe Hypertension defined as Systolic BP > 90 or diastolic > 60
Culture-positive sepsis
Known or strongly suspected inborn errors of metabolism
Significant cardiac disorders, including cyanotic congenital heart disease, ductal-dependent congenital heart disease, and critical congenital heart disease (lesions requiring surgery or catheter-based intervention in the first year of life)
Respiratory failure, defined as any requirement of positive pressure ventilation at the time of enrollment, or FiO2 > 50%
Any other condition, that, in the opinion of the investigator, might interfere with the safe conduct of the study or place the subject at increased risk
Lactic acidosis with at least one or more of the following:
Neonatal Acute Renal Failure, defined as serum creatinine > 2.0 mg/dL with anuria in the first 12 hours of life
Neonatal Acute Hepatic Failure, defined as INR > 3
Liver function test abnormalities defined as AST > 200, ALT > 200, GGT > 100
Electrolyte abnormalities, defined as:
Hyperglycemia (> 150 mg/dL) or hypoglycemia (< 40 mg/dL)
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| Name | Affiliation | Role |
|---|---|---|
| Patrick C Bonasso, MD | University of Arkansas for Medical Sciences (UAMS) | Principal Investigator |
| Samuel Smith, MD | Arkansas Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SoC) Treatment Group | The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons. SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days. |
| FG001 | Direct Peritoneal Resuscitation (DPR) Treatment Group | The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement). SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties. Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SoC) Treatment Group | The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons. SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Days to Full Enteral Feeds | To demonstrate that subjects treated with DPR will have a more benign hospital course as measured by time to full enteral feeds. The primary outcome measure will be time to full feeds of 100 kcal/kg/day. This is assessed once daily on morning rounds by the neonatology team. | Posted | Mean | Standard Error | days | Up to Hospital Discharge (average 30 days) |
|
90 days after treatment
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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 | Standard of Care (SoC) Treatment Group | The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons. SoC Staged Silo Closure: Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Hydronephrosis, Right | Renal and urinary disorders | Systematic Assessment | Severity Scale Grade = 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Bonasso | University of Arkansas for Medical Sciences | (501) 364-2943 | PCBonasso@uams.edu |
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| 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 20, 2018 | Jul 20, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2018 | Jul 20, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D015314 | Dialysis Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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This is a prospective double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis. The experimental arm (DPR group) will receive adjuvant DPR with standard treatment for gastroschisis (staged silo closure). The control arm (SoC group) will receive standard treatment for gastroschisis only. All subjects will be placed in a silo shortly after birth and within 2 hours of admission to the NICU and subsequently serially reduced in silo with umbilical tape until the bowel contents are at the level of fascia and deemed suitable for closure.
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|
|
| Peritoneal Dialysis Solution/Dextrose 1.5% | Drug | Serial reductions will be performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain will be securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe will then be connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed (generally 3-5 days), but not to exceed 7 days maximum. Fluid will be warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion will be 10 mL/kg of dialysate. If tolerated, each subsequent infusion will be increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate will dwell for 1 hour after instillation of fluid. Any excess fluid will then be removed via JP drain. |
|
|
| Days on Total Parental Nutrition (TPN) |
Enteral feeding is begun after orogastric (OG) tube output has stopped and a bowel movement has occurred. OG tube output is checked at least every 4 hours (± 30 minutes) and/or before each feeding per NICU standard practice. Initiation of feeds is a clinical decision based on decreased gastric tube output, abdominal x-rays, and passing of stool. The initiation of enteral feeds is assessed daily on morning rounds by the neonatology team. Feedings start at an average of 7 days following abdominal wall closure. The advancement of enteral feeds will be based on standard practice at ACH. Most feedings are started every six hours and advanced to every three hours as tolerated. |
| Until Day of Discharge, an average of 29 days |
| Days to Intestinal Motility | Motility was quantified as the total number of distinct peristaltic movements visualized in each abdominal quadrant over 30 seconds. A global descriptive score of bowel activity was assigned with the following categories: no, low, normal, or hyperactive peristalsis. The present results are representative of the number of days to return to normal bowel activity. | Up to 3 weeks post-closure |
| Number of Days in the Hospital | Total number of days in the hospital from birth to discharge following staged silo reduction | Until Day of Discharge, an average of 40 days |
| BG001 | Direct Peritoneal Resuscitation (DPR) Treatment Group | The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement). SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties. Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Direct Peritoneal Resuscitation (DPR) Treatment Group | The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement). SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties. Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain. |
|
|
| Secondary | Days to Abdominal Wall Closure | Serial reductions are performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. | Posted | Mean | Standard Error | days | Up to 7 days |
|
|
|
| Secondary | Days on Total Parental Nutrition (TPN) | Enteral feeding is begun after orogastric (OG) tube output has stopped and a bowel movement has occurred. OG tube output is checked at least every 4 hours (± 30 minutes) and/or before each feeding per NICU standard practice. Initiation of feeds is a clinical decision based on decreased gastric tube output, abdominal x-rays, and passing of stool. The initiation of enteral feeds is assessed daily on morning rounds by the neonatology team. Feedings start at an average of 7 days following abdominal wall closure. The advancement of enteral feeds will be based on standard practice at ACH. Most feedings are started every six hours and advanced to every three hours as tolerated. | Posted | Mean | Standard Error | days | Until Day of Discharge, an average of 29 days |
|
|
|
| Secondary | Days to Intestinal Motility | Motility was quantified as the total number of distinct peristaltic movements visualized in each abdominal quadrant over 30 seconds. A global descriptive score of bowel activity was assigned with the following categories: no, low, normal, or hyperactive peristalsis. The present results are representative of the number of days to return to normal bowel activity. | Posted | Mean | Standard Error | days | Up to 3 weeks post-closure |
|
|
|
| Secondary | Number of Days in the Hospital | Total number of days in the hospital from birth to discharge following staged silo reduction | Posted | Mean | Standard Error | days | Until Day of Discharge, an average of 40 days |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Direct Peritoneal Resuscitation (DPR) Treatment Group | The DPR group were placed in silo within 2 hours of admission to the NICU. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects were treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement). SoC Staged Silo Closure: Serial reductions were performed with silastic silo placement for staged reduction using umbilical tape ties. Peritoneal Dialysis Solution/Dextrose 1.5%: Serial reductions were performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain was securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe was connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed for a maximum of 7 days. Fluid was warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion was 10 mL/kg of dialysate. If tolerated, each subsequent infusion was increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate dwelled for 1 hour after instillation of fluid. Any excess fluid was then removed via JP drain. | 0 | 1 | 0 | 1 | 1 | 1 |
|
| Mild Hydronephrosis, Left | Renal and urinary disorders | Systematic Assessment | Severity Scale Grade = 1 |
|
| ABO hemolytic disease of newborn | Blood and lymphatic system disorders | Systematic Assessment | Severity Scale Grade = 1 |
|
| Bilateral pleural effusions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Severity Scale Grade = 2 |
|
| Umbilical MRSA | Infections and infestations | Systematic Assessment | Severity Scale Grade = 1 |
|
| Candida Diaper Rash | Infections and infestations | Systematic Assessment | Severity Scale Grade = 1 |
|
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| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |