Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961904
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-05
Brief Title:
Impact of Breast Milk on Cortical Pain Response in Newborns
Sponsor:
Istanbul Medeniyet University
Organization:
Istanbul Medeniyet University
Study Overview
Official Title:
Impact of Breast Milk on Cortical Pain Response in Newborns During the Heel Prick Procedure A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-07
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:
BackgroundNewborns are exposed to painful procedures for many different reasons in the first days of their life If pain is not relieved effectively in these newborns neurodevelopmental and behavioral problems may occur in the short- and long-term
ObjectiveThis study is aimed to investigate the effects of breast milk on cortical pain response and behavioral response in newborns during heel-prick procedure
Design A prospective randomized controlled trial was conducted on newborns born in a university hospital Healthy-term newborns undergoing heel blood sampling for newborn screening were enrolled in the study Infants were randomly assigned to study group with receive orally 2 ml breast milk n45 or a control group with no intervention n45 before the heel prick A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation rScO2 while neonatal pain expression was assessed by Neonatal Pain Agitation and Sedation Scale N-PASS The rScO2 measure was the primary outcome while the N-PASS score heart rate SaO2 and crying time were the secondary outcomes
ObjectiveThis study is aimed to investigate the effects of breast milk on cortical pain response and behavioral response in newborns during heel-prick procedure
Design A prospective randomized controlled trial was conducted on newborns born in a university hospital Healthy-term newborns undergoing heel blood sampling for newborn screening were enrolled in the study Infants were randomly assigned to study group with receive orally 2 ml breast milk n45 or a control group with no intervention n45 before the heel prick A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation rScO2 while neonatal pain expression was assessed by Neonatal Pain Agitation and Sedation Scale N-PASS The rScO2 measure was the primary outcome while the N-PASS score heart rate SaO2 and crying time were the secondary outcomes
Detailed Description:
During the first few days of life newborns are exposed to painful and stressful procedures1 2 One of these is the metabolic disease screening test using the heel-prick procedures3 4 Newborn screening is crucial to detect several congenital genetic and metabolic disorders at an early stage for the earliest possible recognition and management of affected newborns and to prevent morbidity mortality and disabilities associated with inherited metabolic disorders5 Pain induced by these procedures is ineffectively prevented or inadequately treated1 Consequently this may have short- and long-term negative effects on the pain response and neurodevelopmental outcomes6 7 8 Thus effectively identifying assessing and managing neonatal pain are crucial to minimizing its impact on the intermediate- and long-term outcomes in newborns2 9 Near-infrared spectroscopy NIRS is a noninvasive technique widely used in neonatal pain research to measure functional activation of the cortex20 21 22 23 NIRS has revealed that blood sampling can activate the neonatal somatosensory20 21 motor24 and prefrontal22 areas starting at the 25th week of postmenstrual age Pain increases oxygen consumption with changes occurring in the primary somatosensory cortex on the brain surface25 26 Additionally the relationship between the total Premature Infant Pain Profile PIPP27 score and hemodynamic response has been evaluated
Among the analgesics studied for neonatal pain breast milk is a natural substance beneficial and nutritious for infants32 Whether breast milk administration alters cortical brain activation in neonates is presently unclear Therefore we conducted a trial to assess whether breast milk can relieve cortical pain during a painful metabolic disease screening procedure
Among the analgesics studied for neonatal pain breast milk is a natural substance beneficial and nutritious for infants32 Whether breast milk administration alters cortical brain activation in neonates is presently unclear Therefore we conducted a trial to assess whether breast milk can relieve cortical pain during a painful metabolic disease screening procedure
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