Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475357
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2011-10-06
Brief Title:
Intestinal Function in Neonates With Complex Congenital Heart Disease
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Intestinal Function in Neonates With Complex Congenital Heart Disease
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Postnatal intestinal function in cardiac infants The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology cardiothoracic surgery neonatology microbiology and immunology The hypothesis is that term neonates with complex congenital heart disease CHD who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO nothing by mouth in the pre-operative period
Detailed Description:
The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology cardiothoracic surgery neonatology microbiology and immunology The foundational hypothesis of this proposal is that term neonates 37 weeks gestation with complex congenital heart disease CHD are vulnerable to disturbances in intestinal mucosal function permeability microflora and local immune function which ultimately result in feeding intolerance and poor somatic growth By identifying biologic targets for perioperative intestinal protection this project has the potential to shift and improve the paradigm of perioperative care for neonates with complex CHD This pilot study will generate the data necessary to pursue K23 and R01 funding to further investigate postnatal intestinal maturation and function in neonates with complex CHD and cyanosis specifically as it pertains to local immune function and inflammatory response
The objectives of this proposal are to perform a single-center MUSC prospective randomized pilot trial to investigate postnatal intestinal function in cardiac infants through the following Specific Aims
Specific Aim 1 To compare the decrease in intestinal permeability as determined by urine lactulose mannitol ratios of the trophic breastmilk fed group intervention vs NPO nothing by mouth group current care amongst neonates with complex CHD over 3 different time points postnatal day 3-4 post-operative day 7-8 and post-operative day 13-14
H1 Infants who receive trophic breastmilk feeds in the pre-operative period will demonstrate a more rapid decrease in intestinal permeability improved postnatal intestinal maturation over the first 2 weeks of life compared to those infants who were strictly NPO in the pre-operative period
Specific Aim 2 To compare the duration in days until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs NPO group
H1 Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period
Specific Aim 3 To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs NPO group
H1 The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period
The objectives of this proposal are to perform a single-center MUSC prospective randomized pilot trial to investigate postnatal intestinal function in cardiac infants through the following Specific Aims
Specific Aim 1 To compare the decrease in intestinal permeability as determined by urine lactulose mannitol ratios of the trophic breastmilk fed group intervention vs NPO nothing by mouth group current care amongst neonates with complex CHD over 3 different time points postnatal day 3-4 post-operative day 7-8 and post-operative day 13-14
H1 Infants who receive trophic breastmilk feeds in the pre-operative period will demonstrate a more rapid decrease in intestinal permeability improved postnatal intestinal maturation over the first 2 weeks of life compared to those infants who were strictly NPO in the pre-operative period
Specific Aim 2 To compare the duration in days until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs NPO group
H1 Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period
Specific Aim 3 To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs NPO group
H1 The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period
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