- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303934
Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia
Oral Versus Nasl Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
The efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. Therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy.
Method This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pingdong, Taiwan
- River First Hos.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- meeting the diagnostic criteria of cerebral palsy.
- age<1 year;
- diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;
- with a nasogastric tube inserted at admission;
- enteral nutrition support is required and feasible.
Exclusion Criteria:
- with dysphagia caused by other diseases or factors;
- with progressive neurological disease or degenerative neurological disease;
- with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
- with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
- with poor compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: systemic therapy+Intermittent Oro-Esophageal Tube Feeding
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development.
Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.Within 4 hours of admission, the observation group were required to undergo nasogastric tube removal and initiated Intermittent Oro-Esophageal Tube Feeding for nutrition support.
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All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time. Direct feeding training: with powdered milk, once a day, 5 days a week.
Firstly, the tail of the tube was inserted via mouth into the upper part of the esophagus with a depth of 18-20cm, and the external part of the tube should be placed in water with the absence of bubbles indicating the successful tube placement.
Subsequently, 1ml of water was slowly injected, followed by liquid food or water at a rate of approximately 50ml/min through a syringe connected to the feeding tube.
After feeding, the tube should be slowly removed, and the feeding position should be maintained for 30-60 minutes to prevent reflux.
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Active Comparator: systemic therapy+Persistent Nasogastric Tube Feeding
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development.
Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The control group was given nutrition support with persistent nasogastric tube feeding , of which the tube passed through the nasal cavity into the stomach.
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All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time. Direct feeding training: with powdered milk, once a day, 5 days a week.
After successful intubation, the tube was secured on the cheek.
Liquid food was then syringe-fed into the stomach and the feeding was conducted every 2-3 hours, with each meal not exceeding 200 ml.
The daily intake was generally consistent with that of the observation group.
Besides, after successful intubation, the tube was secured on the infant's face and changed every one to two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Oral Motor Assessment Scale
Time Frame: day 1 and day 90
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The Oral Motor Assessment Scale was a reliable and accurate scale.
It consists of seven items compromising oral-motor skills.
The assessment was conducted with the child in comfortable supported sitting with the head neutral position.
The caregiver was allowed to feed the child one of the following foods normally: fed with a spoon soft food as yoghurt, a solid food as cookie or fed a liquid food with a glass, with/without a straw.
The assessment primarily focused on feeding with 5 types of food (mash, semi-solids, solids, cracker, and liquid bottle/cup).
Throughout the assessment, the examiner didn't interfere with the way the caregiver fed the child but just observed and scored each item of feeding process including chewing, sucking and swallowing.
Each item of The Oral Motor Assessment Scale takes 30 second to be scored as passive (0), sub-functional (1), semi-functional (2) and functional (3).
The final score was positively proportional to swallowing function.
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day 1 and day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hemoglobin
Time Frame: day 1 and day 90
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The examination of hemoglobin levels will be conducted through a complete blood count (CBC) test.
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day 1 and day 90
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Total Protein
Time Frame: day 1 and day 90
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The examination of Total Protein levels will be conducted through a complete blood count (CBC) test.
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day 1 and day 90
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Albumin
Time Frame: day 1 and day 90
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The examination of Albumin levels will be conducted through a complete blood count (CBC) test.
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day 1 and day 90
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Prealbumin
Time Frame: day 1 and day 90
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The examination of Prealbumin levels will be conducted through a complete blood count (CBC) test.
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day 1 and day 90
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body weight
Time Frame: day 1 and day 90
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body weight was assessed with weight scale
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day 1 and day 90
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Penetration-Aspiration Scale
Time Frame: day 1 and day 90
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Penetration-Aspiration Scale is an 8-point scale that measures selected aspects of airway penetration and aspiration.
The score is determined primarily by the depth to which material passes in the airway and whether material entering the airway is expelled.
The scores were negative correlated with the swallowing function
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day 1 and day 90
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Functional Oral Intake Scale for Infants
Time Frame: day 1 and day 90
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The Functional Oral Intake Scale for Infants was also used to assess the feeding and swallowing abilities of infants.
The The Functional Oral Intake Scale for Infants provided a systematic framework for evaluating an infant's level of oral intake.
The minimum values are 0 and maximum values are 7, and higher scores mean a better outcome, better swallowing ability.
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day 1 and day 90
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Pneumonia
Time Frame: day 1 and day 90
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The number of cases of pneumonia in the two groups was respectively recorded at admission and after treatment.
The criteria for pneumonia are: the presence of respiratory infection symptoms such as cough, sputum, fever, and confirmation of inflammatory manifestations
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day 1 and day 90
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Feeding amount
Time Frame: day 1 and day 90
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The volume of all nutrients obtained by the pediatric patients through tube feeding on the same day would be recorded, excluding water, unit: milliliter.
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day 1 and day 90
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOE-NT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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