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临床试验/NCT06700135
NCT06700135尚未招募不适用

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

Cairo University0 个研究点目标入组 30 人开始时间: 2024年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Transition time from tube to full oral feeding

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 120 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •neonates, diagnosed with post-hypoxic ischemic encephalopathy

排除标准

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

研究组 & 干预措施

control group

Active Comparator

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

干预措施: sensorimotor stimulation program sessions (Other)

study group

Experimental

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.

干预措施: sensorimotor stimulation program sessions (Other)

结局指标

主要结局

Transition time from tube to full oral feeding

时间窗: - 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed fekry ibrahim salman

assistant professor

Al-Ahliyya Amman University

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