Trial Outcomes & Findings for Direct Peritoneal Resuscitation in Gastroschisis (NCT NCT03205553)
NCT ID: NCT03205553
Last Updated: 2021-12-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
Up to Hospital Discharge (average 30 days)
Results posted on
2021-12-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Direct Peritoneal Resuscitation in Gastroschisis
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
0 days
STANDARD_DEVIATION 0 • n=5 Participants
|
0 days
n=7 Participants
|
0 days
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Hospital Discharge (average 30 days)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.
Outcome measures
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
|---|---|---|
|
Days to Full Enteral Feeds
|
23.5 days
Standard Error 0.5
|
25 days
|
SECONDARY outcome
Timeframe: Up to 7 daysSerial 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.
Outcome measures
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
|---|---|---|
|
Days to Abdominal Wall Closure
|
4 days
Standard Error 1
|
4 days
|
SECONDARY outcome
Timeframe: Until Day of Discharge, an average of 29 daysEnteral 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.
Outcome measures
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
|---|---|---|
|
Days on Total Parental Nutrition (TPN)
|
21 days
Standard Error 2
|
23 days
|
SECONDARY outcome
Timeframe: Up to 3 weeks post-closureMotility 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.
Outcome measures
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
|---|---|---|
|
Days to Intestinal Motility
|
10.5 days
Standard Error 1.5
|
9 days
|
SECONDARY outcome
Timeframe: Until Day of Discharge, an average of 40 daysTotal number of days in the hospital from birth to discharge following staged silo reduction
Outcome measures
| Measure |
Standard of Care (SoC) Treatment Group
n=2 Participants
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 Participants
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.
|
|---|---|---|
|
Number of Days in the Hospital
|
26 days
Standard Error 2
|
51 days
|
Adverse Events
Standard of Care (SoC) Treatment Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Direct Peritoneal Resuscitation (DPR) Treatment Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care (SoC) Treatment Group
n=2 participants at risk
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.
|
Direct Peritoneal Resuscitation (DPR) Treatment Group
n=1 participants at risk
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.
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|---|---|---|
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Renal and urinary disorders
Mild Hydronephrosis, Right
|
50.0%
1/2 • Number of events 1 • 90 days after treatment
|
0.00%
0/1 • 90 days after treatment
|
|
Renal and urinary disorders
Mild Hydronephrosis, Left
|
50.0%
1/2 • Number of events 1 • 90 days after treatment
|
0.00%
0/1 • 90 days after treatment
|
|
Blood and lymphatic system disorders
ABO hemolytic disease of newborn
|
50.0%
1/2 • Number of events 1 • 90 days after treatment
|
0.00%
0/1 • 90 days after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusions
|
50.0%
1/2 • Number of events 1 • 90 days after treatment
|
0.00%
0/1 • 90 days after treatment
|
|
Infections and infestations
Umbilical MRSA
|
0.00%
0/2 • 90 days after treatment
|
100.0%
1/1 • Number of events 1 • 90 days after treatment
|
|
Infections and infestations
Candida Diaper Rash
|
0.00%
0/2 • 90 days after treatment
|
100.0%
1/1 • Number of events 1 • 90 days after treatment
|
Additional Information
Dr. Patrick Bonasso
University of Arkansas for Medical Sciences
Phone: (501) 364-2943
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place