Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687708
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2023-01-08
Brief Title:
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
Effect of Non-nutritive Sucking Stimulation on Oral Intake and Early Feeding Skills in Newborns With Perinatal Asphyxia A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics and the long transition from tube feeding to oral feeding prolongs the discharge process Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems mother-infant interaction and attachment as well as increasing health expenditures Due to long-term feeding tube use Infection leakage delay in wound healing trauma caused by repeated placement as well as oral reluctance are observed In asphyxia infants in whom oral-motor dysfunction is common the transition to oral feeding takes a long time and tube feeding support is required The effect of hypothermia which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia on oral feeding has been previously studied and shown to have a positive effect They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature Stimulation of non-nutritive sucking NNS is the most frequently preferred method among these interventions It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger and some clinical benefits such as better bottle feeding performance acceleration of discharge and transition to oral feeding
The effect of the NNS stimulation method which has been shown to be effective in preterm infants with large-scale randomized controlled studies is not known exactly
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding feeding skills weight gain and discharge in asphyxia infants receiving hypothermia treatment
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature Stimulation of non-nutritive sucking NNS is the most frequently preferred method among these interventions It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger and some clinical benefits such as better bottle feeding performance acceleration of discharge and transition to oral feeding
The effect of the NNS stimulation method which has been shown to be effective in preterm infants with large-scale randomized controlled studies is not known exactly
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding feeding skills weight gain and discharge in asphyxia infants receiving hypothermia treatment
Detailed Description:
Perinatal asphyxia is the interruption of fetal blood flow or gas exchange during the perinatal period Injury to the brain as a result of systemic hypoxia caused by disruption of gas exchange and slowing of cerebral blood flow is called hypoxic ischemic encephalopathy HIE Perinatal asphyxia may be maternally related or may occur as a result of conditions related to the placenta and the newborn itself It may have etiologies such as maternal diseases such as diabetes hypertension or preeclampsia uterine rupture cord compression congenital airway anomalies of the newborn neurological disorder and severe cardiopulmonary disease According to the World Health Organization WHO report perinatal asphyxia causes 4 million newborn deaths every year and constitutes 23 of total neonatal deaths Asphyxia which has effects such as death seizures and HIE in the short term has effects such as motor disorders such as cerebral palsy sensory disorders such as vision and hearing loss cognitive neurodevelopmental behavioral and emotional disorders in the long term Malnutrition is a problem that can occur both in the short and long term In the short term it may have consequences such as orogastric or nasogastric tube feeding due to sucking andor swallowing dysfunction prolonged feeding times in the long term frequent coughing aspiration pneumonia and gastrostomy The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics and the long transition from tube feeding to oral feeding prolongs the discharge process Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems mother-infant interaction and attachment as well as increasing health expenditures Due to long-term feeding tube use Infection leakage delay in wound healing trauma caused by repeated placement as well as oral reluctance are observed In asphyxia infants in whom oral-motor dysfunction is common the transition to oral feeding takes a long time and tube feeding support is required The effect of hypothermia which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia on oral feeding has been previously studied and shown to have a positive effect They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature Stimulation of non-nutritive sucking NNS is the most frequently preferred method among these interventions It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger and some clinical benefits such as better bottle feeding performance acceleration of discharge and transition to oral feeding
The effect of the NNS stimulation method which has been shown to be effective in preterm infants with large-scale randomized controlled studies is not known exactly The NNS stimulation method applied in a newborn with severe asphyxia with medical complications was investigated in a case study and it was pointed out that it could have positive results but more research should be done in this patient group
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding feeding skills weight gain and discharge in asphyxia infants receiving hypothermia treatment
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature Stimulation of non-nutritive sucking NNS is the most frequently preferred method among these interventions It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger and some clinical benefits such as better bottle feeding performance acceleration of discharge and transition to oral feeding
The effect of the NNS stimulation method which has been shown to be effective in preterm infants with large-scale randomized controlled studies is not known exactly The NNS stimulation method applied in a newborn with severe asphyxia with medical complications was investigated in a case study and it was pointed out that it could have positive results but more research should be done in this patient group
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding feeding skills weight gain and discharge in asphyxia infants receiving hypothermia treatment
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