Comparison of Intermittent Oro-Esophageal Tube Feeding in Infants With Cerebral Palsy and Dysphagia

Comparison of Intermittent Oro-Esophageal Tube Feeding Versus Persistent Nasogastric Tube Feeding 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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: systemic therapy; Device: Intermittent Oro-Esophageal Tube Feeding; Device: Persistent Nasogastric Tube Feeding

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zheng da yi fu yuan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the observation group; 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.	Behavioral: systemic therapy; 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.; Device: Intermittent Oro-Esophageal Tube Feeding; 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.
Active Comparator: The control group; 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.	Behavioral: systemic therapy; 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.; Device: Persistent Nasogastric Tube Feeding; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1 and day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1 and day 90
Hemoglobin	The examination of hemoglobin levels will be conducted through a complete blood count (CBC) test.	day 1 and day 90
Total Protein	The examination of Total Protein levels will be conducted through a complete blood count (CBC) test.	day 1 and day 90
Albumin	The examination of Albumin levels will be conducted through a complete blood count (CBC) test.	day 1 and day 90
Prealbumin	The examination of Prealbumin levels will be conducted through a complete blood count (CBC) test.	day 1 and day 90
body weight	body weight was assessed with weight scale	day 1 and day 90
upper arm circumference	upper arm circumference was assessed with the tape.	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	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.	day 1, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 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.	day 1 and day 90

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Investigators: Study Chair: Nieto Luis, Site Coordinator of United Medical Group located in Miami

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2022-KY-1532-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The authors do not have permission to share data. But the full trial protocol and data can be obtained from the first affiliated hospital of zhengzhou university under a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No