Cerebral PalsyNCT06185504

Comparison of Intermittent Oro-Esophageal Tube Feeding 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 Zeng Changhao at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 Up 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: Pill or oral medicine, 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 siteChina
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 Up to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
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.

China1 site

Zheng da yi fu yuan hospital
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Comparison of Intermittent Oro-Esophageal Tube Feeding Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study

Read the detailed description

In China, for nutrition support in the infants under one year of age with cerebral palsy and dysphagia, persistent nasogastric tube feeding is the mainstream choice. However, 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
1. The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.
2. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.
3. 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.
4. Direct feeding training: with powdered milk, once a day, 5 days a week.
Intermittent Oro-Esophageal Tube FeedingDevice
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. Before each feeding, the infant should rest for approximately 1 hour and undergo oral clean. During feeding, the infant should be held by the caregiver in a semi-reclined or upright position. 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
The control group was given nutrition support with Persistent Nasogastric Tube Feeding, of which the tube passed through the nasal cavity into the stomach. 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 groups in NCT06185504
Study group	Role	What they receive
the observation group	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
The control group	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 (10)

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 by lung CT.
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
upper arm circumference
upper arm circumference was assessed with the tape.
Measured: day 1 and day 90
Penetration-Aspiration Scale
Rhe 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
The 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, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 and day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202230 Jun 2023

First posted29 Dec 2023
Study start1 Jan 2022
Primary completion15 Jun 2023
Study completion30 Jun 2023

Why it stopped: ethical issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06185504
Sponsor's protocol ID: 2022-KY-1532-001
Status last verified: Mar 2024
First submitted: 15 Dec 2023
Last updated: 5 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598
Jiang H, Li X, Jin C, Wang M, Liu C, Chan KC, Yang J. Early Diagnosis of Spastic Cerebral Palsy in Infants with Periventricular White Matter Injury Using Diffusion Tensor Imaging. AJNR Am J Neuroradiol. 2019 Jan;40(1):162-168. doi: 10.3174/ajnr.A5914. Epub 2018 Dec 13.
PubMed 30545838

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Intermittent Oro-Esophageal Tube Feeding Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT06185504
Acronym / sponsor ID: 2022-KY-1532-001
Conditions: Cerebral Palsy
Study type: Interventional
Recruitment status: TerminatedReason stopped: ethical issues
Enrolment: 80 participants (actual)
Lead sponsor: Zeng ChanghaoUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 15 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 29 Dec 2023 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
the observation group	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.
The control group	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: Up to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
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 1. The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. 2. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. 3. 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. 4. Direct feeding training: with powdered milk, once a day, 5 days a week.	Behavioural	The control group, the observation group
Intermittent Oro-Esophageal Tube FeedingWithin 4 hours of admission, the observation group were required to undergo nasogastric tube removal and initiated Intermittent Oro-Esophageal Tube Feeding for nutrition support. Before each feeding, the infant should rest for approximately 1 hour and undergo oral clean. During feeding, the infant should be held by the caregiver in a semi-reclined or upright position. 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.	Device	the observation group
Persistent Nasogastric Tube FeedingThe control group was given nutrition support with Persistent Nasogastric Tube Feeding, of which the tube passed through the nasal cavity into the stomach. 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.	Device	The control group

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.

10 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
upper arm circumference
Time frame: day 1 and day 90
Penetration-Aspiration Scale
Time frame: day 1 and day 90
The Functional Oral Intake Scale for Infants
Time frame: day 1 and day 90
Feeding amount
Time frame: day 1, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 and day 90

Results and safety

The study was stopped early (reason given: ethical issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Background: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
Background: PubMed 30545838Jiang H, Li X, Jin C, Wang M, Liu C, Chan KC, Yang J. Early Diagnosis of Spastic Cerebral Palsy in Infants with Periventricular White Matter Injury Using Diffusion Tensor Imaging. AJNR Am J Neuroradiol. 2019 Jan;40(1):162-168. doi: 10.3174/ajnr.A5914. Epub 2018 Dec 13.
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 study chair

Site Coordinator of United Medical Group located in Miami

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 Zeng Changhao at 1 site in China.

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: stopped early, as of the sponsor's last update on 5 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 China. 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 was stopped early (reason given: ethical issues). Results are not available in the source record.

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?

On the ClinicalTrials.gov record for NCT06185504, which also lists 2 linked publications.

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 5 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.