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

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). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Conditions

• Cerebral Palsy

Interventions

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 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.

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.

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.

Sponsors & Collaborators

• Zeng Changhao

  lead OTHER

Principal Investigators

• Nieto Luis · Site Coordinator of United Medical Group located in Miami

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-06-15

Completion

2023-06-30

Countries

• China

Study Locations