Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.

Launched by TANG-DU HOSPITAL · Jul 22, 2025

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ClinConnect Summary

This clinical trial is studying whether a special type of nutrition called semi-elemental enteral nutrition (SEN) can help people with severe traumatic brain injury (TBI) better tolerate feeding through a tube into their stomach or intestines. The goal is to see if SEN can reduce problems with digestion and improve overall health outcomes after a serious brain injury. The study will also check if this type of nutrition is safe for patients.

Adults aged 18 to 75 who have had a serious brain injury and need feeding through a tube within 48 hours of their injury may be eligible to join. Participants will be randomly assigned to receive either the special semi-elemental nutrition or the usual tube feeding for at least a week. The study will monitor how well their digestive system handles the nutrition and look at their recovery progress. People with certain other health problems or conditions may not be eligible. If you or a loved one fits the criteria and is receiving care for severe brain injury, this trial might be an option to consider with your healthcare team.

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Eligibility criteria

• Inclusion Criteria:
• • Aged 18-75 years;
• • Clinically diagnosed with closed traumatic brain injury;
• • Glasgow Coma Scale (GCS) score ≤ 8;
• • Ability to initiate enteral nutrition within 48 hours post-injury;
• • Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 \[NRS2002\] score ≥3).
• Exclusion Criteria:
• • GCS=3 with bilateral fixed and dilated pupils;
• • Hemodynamic instability or respiratory failure: mean arterial pressure \<70mmHg, PaO2/FiO2\<150, PaCO2\<30 mmHg or \>45 mmHg, or lactate \>5 mmol/l;
• • Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;
• • Contraindications to enteral nutrition therapy or semi-recumbent positioning;
• • Pre-existing intellectual disability or physical disability affecting outcome assessment;
• • Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122 cm), ulcerative colitis, Crohn's disease, or any form of ostomy;
• • Body mass index (BMI) \<18kg/m2;
• • Concomitant abdominal injury or extracranial injury with AIS score \>3 in any region;
• • Presence of malignancy, severe cardiac insufficiency (ejection fraction \<50%), severe hepatic failure (Child-Pugh score ≥7), or severe renal failure (glomerular filtration rate ≤30 mL/min or serum creatinine ≥4mg/dL) at NICU admission;
• • Concurrent severe disease with expected survival ≤14 days;
• • Pregnancy, within 30 days postpartum, or breastfeeding;
• • Refusal of treatment or receipt of palliative care;
• • Patient or family declines informed consent;
• • Current participation in another interventional clinical trial.