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NCT Number: NCT06700135

Sensorimotor Stimulation on Oral Feeding

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sensorimotor stimulation program sessions

Other

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 outcomes

  1. 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

    the number of days from the commencement of the intervention to the first day of exclusive oral feeding.

  2. 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

    this is the number of days from the beginning of oral feeding until discharge.

Secondary outcomes

  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

    this is the number of days from the start of the oral stimulation program until discharge from the NICU.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed fekry Salman, PhD

CONTACT

[email protected]

+962797168340

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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