Semi-elemental tube feeding to improve gut tolerance after severe traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with severe closed TBI (GCS ≤8) who can start enteral nutrition within 48 hours will be randomized 1:1 to receive either a semi-elemental enteral formula or standard enteral nutrition. The assigned feeding is continued for at least seven days while patients are monitored during the acute phase. The primary outcome is gastrointestinal tolerance in the first seven days; secondary outcomes include specific GI complications (diarrhea, vomiting, gastroparesis, abdominal distension), ICU and hospital length of stay, six-month mortality and functional recovery, and safety events such as infections. The trial tests whether a hydrolyzed, low-osmolality formula reduces digestive burden and improves mucosal function and clinical recovery compared with standard feeding.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tangdu Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Haixiao Liu, MD, PhD
• Email: hai_xiao_liu@163.com
• Phone: +86-029-84717556

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.