Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331201
Status:
COMPLETED
Last Update Posted:
2006-11-28
First Post:
2006-05-25
Brief Title:
SAFEstart Feeding Intolerance Study Phase II
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
SAFEstart Treatment for NICU Patients With Feeding Intolerance a Phase II Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Feeding intolerance is a common problem in the NICU Feeding intolerance complicates the hospitalization lengthens the hospital stay and adds substantially to the cost of care We developed a method aimed at treating intestinal villous atrophy We accomplished preclinical testing of the product and four Phase I clinical trials including two at McKay-Dee Hospital in 2004 Our preparation is a sterile isotonic solution that simulates human amniotic fluid in electrolyte composition albumin concentration and two enterocyte growth factors that are present in human amniotic fluid erythropoietin and granulocyte colony-stimulating factor We termed the product SAFEstart using the acronym Simulated Amniotic Fluid for Enteral administration This trial on the efficacy and safety of SAFEstart administration as a treatment for neonates who have feeding intolerance
Hypothesis is that infants with feeding intolerance randomized to the SAFEstart will have a greater enteral calories per kilogram per day for the seven days following conclusion of the SAFEstart administration
Hypothesis is that infants with feeding intolerance randomized to the SAFEstart will have a greater enteral calories per kilogram per day for the seven days following conclusion of the SAFEstart administration
Detailed Description:
Feeding intolerance is relatively common in the NICU It can manifest as emesis diarrhea increased abdominal girth bloating or in the most severe cases as necrotizing enterocolitis Feeding intolerance complicates the hospitalization lengthens the hospital stay and adds substantially to the cost of care Feeding intolerance likely has many causes One cause that may be particularly common in the NICU is atrophy of the intestinal mucosa which occurs during enteral fasting when a patient is NPO Significant intestinal villous atrophy occurs after being NPO for even 1-2 days even if parenteral nutrition is adequate
We developed a method aimed at preventing intestinal villous atrophy of neonates who are NPO We accomplished preclinical testing of the product and we completed two Phase I clinical trials involving 60 neonates Our preparation is a sterile isotonic solution that simulates human amniotic fluid in electrolyte composition albumin concentration and two enterocyte growth factors that are present in human amniotic fluid erythropoietin and granulocyte colony-stimulating factor We termed the product SAFEstart using the acronym Simulated Amniotic Fluid for Enteral administration
SAFEstart has been tested in neonates who have never been fed as a means of preventing villous mucosal atrophy However it has not yet been tested in neonates who develop feeding intolerance after several days or weeks of life When feeding intolerance develops in such patients the current treatments include changing formulas continuous feeding but does not include using SAFEstart
It is possible that SAFEstart administration 25 mLkg enterally every three hours as we have previously done with preterm neonates beginning on the first day of life would provide benefit to these older neonates with acquired feeding intolerance If such infants have mucosal atrophy as part of their feeding problem the growth factors in SAFEstart might indeed result in improved feeding tolerance
We propose a Phase II exploratory trial among 20 neonates in the McKay-Dee NICU who develop the problem of feeding intolerance Specifically we propose that when feeding intolerance is diagnosed 20 mLkgday of SAFEstart will be administered every three hour gavage or nipple feedings and that this will be continued for a period of up to one week in an attempt to resolve the feeding intolerance
We developed a method aimed at preventing intestinal villous atrophy of neonates who are NPO We accomplished preclinical testing of the product and we completed two Phase I clinical trials involving 60 neonates Our preparation is a sterile isotonic solution that simulates human amniotic fluid in electrolyte composition albumin concentration and two enterocyte growth factors that are present in human amniotic fluid erythropoietin and granulocyte colony-stimulating factor We termed the product SAFEstart using the acronym Simulated Amniotic Fluid for Enteral administration
SAFEstart has been tested in neonates who have never been fed as a means of preventing villous mucosal atrophy However it has not yet been tested in neonates who develop feeding intolerance after several days or weeks of life When feeding intolerance develops in such patients the current treatments include changing formulas continuous feeding but does not include using SAFEstart
It is possible that SAFEstart administration 25 mLkg enterally every three hours as we have previously done with preterm neonates beginning on the first day of life would provide benefit to these older neonates with acquired feeding intolerance If such infants have mucosal atrophy as part of their feeding problem the growth factors in SAFEstart might indeed result in improved feeding tolerance
We propose a Phase II exploratory trial among 20 neonates in the McKay-Dee NICU who develop the problem of feeding intolerance Specifically we propose that when feeding intolerance is diagnosed 20 mLkgday of SAFEstart will be administered every three hour gavage or nipple feedings and that this will be continued for a period of up to one week in an attempt to resolve the feeding intolerance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None