Impact of Folic Acid and Vitamin B12 on Children's Postoperative Recovery
Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children
This study is testing if giving children folic acid and vitamin B12 before surgery can help them recover better and avoid confusion after having anesthesia for head and neck surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04456985 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of preoperative supplementation with folic acid and vitamin B12 on postoperative delirium and long-term neurobehavioral outcomes in children undergoing general anesthesia for head, neck, and maxillofacial surgeries. The research aims to understand how these vitamins, which play crucial roles in nervous system function and cognitive health, can mitigate cognitive impairments associated with anesthesia. By comparing outcomes in children receiving these supplements to those receiving a placebo, the study seeks to provide insights into improving postoperative care for young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 2 years who are scheduled for specific surgeries under general anesthesia lasting less than 6 hours.
Not a fit: Patients with central nervous system diseases, congenital malformations, or those who have recently taken medications affecting absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of postoperative delirium and enhance cognitive recovery in children after surgery.
How similar studies have performed: Previous studies have indicated that folic acid supplementation can alleviate cognitive impairments in animal models, suggesting potential for success in similar human applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA grade is Ⅰ \~ Ⅱ; 2. Children aged 6 months to 2 years old; 3. It is planned to undergo head, neck and maxillofacial surgery under general anesthesia with anesthesia for less than 6 hours Exclusion Criteria: 1. Children with a history of respiratory tract infection within 1 week; 2. Children with congenital malformations such as congenital heart disease; 3. Children with central nervous system diseases or mental disorders or mental disorders; 4. Children with long-term use of sedative or analgesic drugs; 5. Children with severe liver and kidney dysfunction; 6. Received folic acid and VitB12 supplement treatment or taken related derivatives; 7. Have taken drugs that affect absorption within the past month, such as sulfonamides, aspirin, etc .; 8. Those who have participated in other relevant clinical research in the past 3 months; 9. Children with stunting
Where this trial is running
Shanghai, Shanghai
- China — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: lei zhang, Doctor
- Email: weiymzhl@126.com
- Phone: 0086-18717822662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.