Cerebral PalsyNCT06303934
Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia
A study testing systemic therapy, Intermittent Oro-Esophageal Tube Feeding and Persistent Nasogastric Tube Feeding in people with Cerebral Palsy, run by Muhammad at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- systemic therapy, Intermittent Oro-Esophageal Tube Feeding and Persistent Nasogastric Tube Feeding
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Versus Nasl Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- systemic therapy, Intermittent Oro-Esophageal Tube Feeding, Persistent Nasogastric Tube Feeding
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic therapyBehavioural
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.
Intermittent Oro-Esophageal Tube FeedingDevice
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.
Persistent Nasogastric Tube FeedingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| systemic therapy+Intermittent Oro-Esophageal Tube Feeding | Experimental | 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. Receives: Behavioral: systemic therapy; Device: Intermittent Oro-Esophageal Tube Feeding |
| systemic therapy+Persistent Nasogastric Tube Feeding | Active comparator | 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. Receives: Behavioral: systemic therapy; Device: Persistent Nasogastric Tube Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oral Motor Assessment Scale
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.
Measured: day 1 and day 90
Secondary outcomes (9)
Pneumonia
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
Measured: day 1 and day 90
Hemoglobin
The examination of hemoglobin levels will be conducted through a complete blood count (CBC) test.
Measured: day 1 and day 90
Total Protein
The examination of Total Protein levels will be conducted through a complete blood count (CBC) test.
Measured: day 1 and day 90
Albumin
The examination of Albumin levels will be conducted through a complete blood count (CBC) test.
Measured: day 1 and day 90
Prealbumin
The examination of Prealbumin levels will be conducted through a complete blood count (CBC) test.
Measured: day 1 and day 90
body weight
body weight was assessed with weight scale
Measured: day 1 and day 90
Penetration-Aspiration Scale
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
Measured: day 1 and day 90
Functional Oral Intake Scale for Infants
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.
Measured: day 1 and day 90
Feeding amount
The volume of all nutrients obtained by the pediatric patients through tube feeding on the same day would be recorded, excluding water, unit: milliliter.
Measured: day 1 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2022
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad, Ahmadu Bello University Teaching Hospital
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303934
- Sponsor's protocol ID
- IOE-NT
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Nasl Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06303934
- Acronym / sponsor ID
- IOE-NT
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MuhammadUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic therapy+Intermittent Oro-Esophageal Tube Feeding | Experimental | Behavioral: systemic therapy, Device: Intermittent Oro-Esophageal Tube FeedingAll 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. |
| systemic therapy+Persistent Nasogastric Tube Feeding | Active comparator | Behavioral: systemic therapy, Device: Persistent Nasogastric Tube FeedingAll 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. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic therapyAll 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. | Behavioural | systemic therapy+Intermittent Oro-Esophageal Tube Feeding, systemic therapy+Persistent Nasogastric Tube Feeding |
| Intermittent Oro-Esophageal Tube FeedingFirstly, 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. | Device | systemic therapy+Intermittent Oro-Esophageal Tube Feeding |
| Persistent Nasogastric Tube FeedingAfter 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. | Device | systemic therapy+Persistent Nasogastric Tube Feeding |
Primary outcome
The Oral Motor Assessment Scale
Time frame: day 1 and day 90
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.
9 secondary outcomes
Pneumonia
Time frame: day 1 and day 90
Hemoglobin
Time frame: day 1 and day 90
Total Protein
Time frame: day 1 and day 90
Albumin
Time frame: day 1 and day 90
Prealbumin
Time frame: day 1 and day 90
body weight
Time frame: day 1 and day 90
Penetration-Aspiration Scale
Time frame: day 1 and day 90
Functional Oral Intake Scale for Infants
Time frame: day 1 and day 90
Feeding amount
Time frame: day 1 and day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systemic therapy, Intermittent Oro-Esophageal Tube Feeding and Persistent Nasogastric Tube Feeding in people with Cerebral Palsy, run by Muhammad at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oral Motor Assessment Scale (time frame: day 1 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.