Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447155
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-06-03
Brief Title:
Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Sponsor:
Istanbul Training and Research Hospital
Organization:
Istanbul Training and Research Hospital
Study Overview
Official Title:
The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Therapeutic hypothermia TH is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy HIE
While central nervous system is the most affected organ system multiorgan dysfunction including renal pulmonary cardiac andor gastrointestinal GI compromise is not infrequent Although the process of cooling itself is well defined based on high-quality randomized controlled trials there are few data to inform the provision of nutrition to infants with HIE during and soon after THHowever breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut It may help to reduce systemic inflammatory response and positively regulates the microbiota In many studies it is stated that enteral feeding during TH appears to be safe and feasible There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH
The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH
While central nervous system is the most affected organ system multiorgan dysfunction including renal pulmonary cardiac andor gastrointestinal GI compromise is not infrequent Although the process of cooling itself is well defined based on high-quality randomized controlled trials there are few data to inform the provision of nutrition to infants with HIE during and soon after THHowever breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut It may help to reduce systemic inflammatory response and positively regulates the microbiota In many studies it is stated that enteral feeding during TH appears to be safe and feasible There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH
The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH
Detailed Description:
Objectives The investigators aimed to evaluate the clinical consequences of different types of enteral nutrition during TH in babies with HIE
Methods This single-center prospective randomized controlled trial RCT was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital A cohort of 60 infants with HIE born at 35 07 to 42 67 weeks of gestation who received TH were enrolled
The infants enterally fed with bolus feeding during hypothermia n 20 those who were fed continuously n20 constituted the study groups The control group n 20 was composed of neonates who were not fed Infants were monitored for clinical consequences such as feeding intolerance time to full enteral feeding duration of hospitalization necrotizing enterocolitis and mortality
Methods This single-center prospective randomized controlled trial RCT was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital A cohort of 60 infants with HIE born at 35 07 to 42 67 weeks of gestation who received TH were enrolled
The infants enterally fed with bolus feeding during hypothermia n 20 those who were fed continuously n20 constituted the study groups The control group n 20 was composed of neonates who were not fed Infants were monitored for clinical consequences such as feeding intolerance time to full enteral feeding duration of hospitalization necrotizing enterocolitis and mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None