Sensorimotor Stimulation on Oral Feeding

Not Applicable

Not yet recruiting

• Conditions: Neonates Post Hypoxic Ischemic Encephalopathy

• Registration Number: NCT06700135
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Start: 2024-11-28
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transition time from tube to full oral feeding	- 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.
Time taken to accomplish exclusive oral feeding	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 Outcome Measures

Name	Time	Method
Total hospital stay	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.