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

NCT05687708 | Completed

• 1 other identifier: MedipolDKT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  1 month

• Time from tube feeding to oral intake

  how many days the baby transitions from tube feeding to oral intake

  20 days

Secondary Outcomes (2)

• discharge time

  1 month

• weight gain

  1 month

Study Arms (2)

Non-Nutritive Sucking

EXPERIMENTAL

Non-Nutritive Sucking

Other: Non-Nutritive Sucking

Control

NO INTERVENTION

routine treatment

Interventions

Non-Nutritive Sucking OTHER

NNS is stimulated by giving stimulus into the baby's mouth with the help of a finger wearing gloves.

Non-Nutritive Sucking

Eligibility Criteria

• Age: 34 Months - 41 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to be diagnosed with asphyxia,
• to have received hypothermia treatment,
• to have started enteral nutrition,
• to have physiological stability to tolerate NNS stimulation.

You may not qualify if:

• Having a craniofacial anomaly,
• having a congenital anomaly,
• being referred to another center/hospital during treatment.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 22366642 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Hypoxia-Ischemia, Brain; Communication Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Seyhun Topbas

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student, Speech and Language Therapist

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: November 1, 2021
• Primary Completion: May 20, 2023
• Study Completion: July 25, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)