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Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

Primary Purpose

Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-Nutritive Sucking
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Swallowing Disorder focused on measuring perinatal asphyxia, non-nutritive sucking, oral feeding, oral stimulation

Eligibility Criteria

34 Months - 41 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: to be diagnosed with asphyxia, to have received hypothermia treatment, to have started enteral nutrition, to have physiological stability to tolerate NNS stimulation. Exclusion Criteria: Having a craniofacial anomaly, having a congenital anomaly, being referred to another center/hospital during treatment.

Sites / Locations

  • Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Non-Nutritive Sucking

Control

Arm Description

Non-Nutritive Sucking

routine treatment

Outcomes

Primary Outcome Measures

Early Feeding Skills Assessment Tool
are the scores obtained by the clinician from the early feeding assessment tool. The minimum score that can be obtained from the scale is 19, and the maximum score is 57. A higher score indicates better feeding skills.
Time from tube feeding to oral intake
how many days the baby transitions from tube feeding to oral intake

Secondary Outcome Measures

discharge time
how many days the baby is discharged from the neonatal intensive care unit
weight gain
is the weight information of the baby at certain intervals

Full Information

First Posted
January 8, 2023
Last Updated
October 5, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05687708
Brief Title
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
Official Title
Effect of Non-nutritive Sucking Stimulation on Oral Intake and Early Feeding Skills in Newborns With Perinatal Asphyxia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 and/or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood, Hypoxic-Ischemic Encephalopathy, Speech Therapy
Keywords
perinatal asphyxia, non-nutritive sucking, oral feeding, oral stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Nutritive Sucking
Arm Type
Experimental
Arm Description
Non-Nutritive Sucking
Arm Title
Control
Arm Type
No Intervention
Arm Description
routine treatment
Intervention Type
Other
Intervention Name(s)
Non-Nutritive Sucking
Intervention Description
NNS is stimulated by giving stimulus into the baby's mouth with the help of a finger wearing gloves.
Primary Outcome Measure Information:
Title
Early Feeding Skills Assessment Tool
Description
are the scores obtained by the clinician from the early feeding assessment tool. The minimum score that can be obtained from the scale is 19, and the maximum score is 57. A higher score indicates better feeding skills.
Time Frame
1 month
Title
Time from tube feeding to oral intake
Description
how many days the baby transitions from tube feeding to oral intake
Time Frame
20 days
Secondary Outcome Measure Information:
Title
discharge time
Description
how many days the baby is discharged from the neonatal intensive care unit
Time Frame
1 month
Title
weight gain
Description
is the weight information of the baby at certain intervals
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Months
Maximum Age & Unit of Time
41 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: to be diagnosed with asphyxia, to have received hypothermia treatment, to have started enteral nutrition, to have physiological stability to tolerate NNS stimulation. Exclusion Criteria: Having a craniofacial anomaly, having a congenital anomaly, being referred to another center/hospital during treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyhun Topbas
Organizational Affiliation
Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Medipol University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22366642
Citation
Harding C, Frank L, Dungu C, Colton N. The use of nonnutritive sucking to facilitate oral feeding in a term infant: a single case study. J Pediatr Nurs. 2012 Dec;27(6):700-6. doi: 10.1016/j.pedn.2012.01.006. Epub 2012 Feb 22.
Results Reference
background

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Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

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