An interventional study of sensorimotor stimulation program sessions in Neonates Post Hypoxic Ischemic Encephalopathy, sponsored by Cairo University. Not yet recruiting. Open to participants aged 1 Day to 120 Days. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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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
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
the control group, which comprised 15 neonates, received only traditional medical treatment.
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.
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.
Transition time from tube to full oral feeding
the number of days from the commencement of the intervention to the first day of 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
Time taken to accomplish exclusive oral feeding
this is the number of days from the beginning of oral feeding until discharge.
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
Total hospital stay
this is the number of days from the start of the oral stimulation program until discharge from the NICU.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Jan 2025, 1 month later.
Of 46 non-industry interventional studies with no phase under Hypoxia-Ischemia, Brain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's planned 1 month is below that.
Counting every sponsor, half of 47 studies reached it within 33 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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