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Not yet recruiting NCT06700135

Sensorimotor Stimulation on Oral Feeding

No phase Interventional Neonates Post Hypoxic Ischemic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sensorimotor stimulation program sessions.
Who it may be relevant to
Registry conditions: Neonates Post Hypoxic Ischemic Encephalopathy. Basic parameters: 1 Day — 120 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Sensorimotor Stimulation on Oral Feeding Skills for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit

Overview

Background: Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are significant causes of irreversible adverse neurodevelopmental outcomes in children. Neonates and infants with HIE commonly experience difficulties in learning the oromotor skills of sucking, swallowing, and breathing. These feeding problems can lead to severe complications such as weight loss, dehydration, malnutrition, and developmental deficits. Objective: The study aims to assess the efficacy of sensorimotor stimulation intervention on oral skills in neonates with post-hypoxic ischemic encephalopathy in the neonatal intensive care unit (NICU). Methods: The study will include thirty infants with hypoxic-ischemic encephalopathy. They will be divided into two equal groups: The study group receive traditional medical treatment as well as a sensorimotor stimulation program, whereas the control group receive only traditional medical treatment

Interventions

  • Other sensorimotor stimulation program sessions
    The study group, consisting of 15 neonates, received traditional medical treatment along with sensorimotor stimulation program sessions. These sessions included oral stimulation protocol, Tactile/Kinesthetic (T/K) intervention, feeding position, and oral support.

Primary outcome measures

  • Transition time from tube to full oral feeding [Time frame: - At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period (Premji et]
  • Time taken to accomplish exclusive oral feeding [Time frame: At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period (Premji et a]
Secondary outcome measures (1)
  • Total hospital stay [Time frame: At least one-time breast feeding in a 24-hour period (Fucile et al., 2013). - Consuming eight feedings per day for two consecutive days. - Capable of consuming orally over 80% of the recommended total fluid intake within a 24-hour period]

Eligibility criteria

Inclusion criteria

  • neonates, diagnosed with post-hypoxic ischemic encephalopathy

Exclusion criteria

  • Neonates with congenital anomalies affecting the oral-facial area,
  • or syndromes associated with developmental delays,
  • chronic medical complications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06700135 · sensorimotor stimuli

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗