Sensorimotor Stimulation on Oral Feeding

NCT ID: NCT06700135

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2025-01-05

Brief Summary

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

Conditions

Neonates Post Hypoxic Ischemic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

the control group, which comprised 15 neonates, received only traditional medical treatment.

Group Type: ACTIVE_COMPARATOR

sensorimotor stimulation program sessions

Intervention Type: 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.

study group

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.

Group Type: EXPERIMENTAL

sensorimotor stimulation program sessions

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 120 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed fekry ibrahim salman

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed fekry Salman, PhD

Role: CONTACT

a.salman@ammanu.edu.jo

+962797168340

Other Identifiers

sensorimotor stimuli

Identifier Type: -

Identifier Source: org_study_id