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This study is a prospective, single center, practical, and observational open clinical study.
Infant enterostomy is one of the emergency surgeries in pediatric gastroenterology. The most common underlying conditions during infancy include necrotizing enterocolitis, intestinal necrosis, intestinal perforation, and congenital gastrointestinal malformations. Necrotizing enterocolitis also serves as a major cause of short bowel syndrome in infants. Infants with small bowel stoma leading to short bowel syndrome face a higher incidence of complications compared to adults. Additionally, small intestinal stomy inevitably come with various complications such as infection, electrolyte imbalance, nutrient deficiencies, and malnutrition.
Currently, both domestic and international studies have shown that breast milk is the preferred choice for infant nutrition. The benefits of breastfeeding have been widely reported. For postoperative infants with digestive tract surgery, breast milk's immunoglobulins and prebiotics can help promote beneficial gut bacteria and bioactive proteins (such as lactoferrin, lysozyme, and lipoproteins), growth factors that facilitate intestinal adaptation and maturation processes while enhancing feeding tolerance and preventing infections or inflammatory disorders.
However, according to literature reports on clinical practice operations after digestive tract surgery even if early breastfeeding was initiated in 88% of cases; only 44% of infants were still being breastfed at discharge. This is due to feeding intolerance following breastfeeding which manifests as gastric retention, abdominal distension, diarrhea etc., not only delaying growth but also prolonging hospital stay while causing other adverse clinical outcomes. Some discharged infants who started breastfeeding experienced diarrhea and dehydration leading to readmission. Clinically speaking this issue has often been addressed by substituting feeds with enteral nutrition preparations (deep hydrolyzed formulas or free amino acid formulas).
The objective of this study is to assess the impact of enteral nutrition, which involves selecting appropriate preparations and human breast milk based on the child's intestinal tolerance, on growth and developmental outcomes in children following enterostomy. Additionally, we aim to investigate its effects on postoperative intestinal permeability, stoma output, gut microbiota and metabolites, sepsis incidence, colitis occurrence as well as bile stasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enteral nutrition | Infants, undergo enterostomy for various reasons within the age range of 0-6 months.The enteral nutrition can be administered orally or via enteral nutrition, including breast milk, preterm formula, infant formula, extensive hydrolyzed formula or amino acid formula et al .To observe and study the efficacy, safety and tolerance of enteral nutrition in infants after enterostomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Z-scores of body weight | The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) was obtained from the World Health Organization Anthro software and WHO Child Growth Standards. | 4 weeks after enteral feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Z-scores of body length | The patient's body length will be measured on the electronic infant scale. Z-scores for weight for age (WAZ) was obtained from the World Health Organization Anthro software and WHO Child Growth Standards. | 4 weeks day after enteral feeding |
| The change of ostomy volume |
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Inclusion Criteria:
Exclusion Criteria:
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Infants, undergo enterostomy for various reasons within the age range of 0-6 months
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Qian, M.D. | Contact | 02164931981 | drqiantian@fudan.edu.cn | |
| Yiyao Zhou, Bachelor | Contact | 02164931980 | kerry_zyy@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Tian Qian, M.D. | Children's Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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The amount of fistula form the ostomy bag will be recorded at the first day, the 14th day and the 28th day of the enteral nutrition. |
| From the the day starting the enteral nutrition to the fourth week. |
| Z-scores of head circumference | Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. | 4 weeks day after enteral feeding |
| Cholestasis | The diagnostic criteria include the requirement of parenteral nutrition administration for a duration exceeding 2 weeks and an elevated direct bilirubin level > 34 mmol/L | 4 weeks day after enteral feeding |
| The incidence rate of septicemia | The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of septicemia in pediatric patients following enterostomy | Prior to complete enteral nutrition |
| The incidence rate of colitis | The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of colitis in pediatric patients following enterostomy | Prior to complete enteral nutrition |
| D-lactic acid | Effect of enteral nutrition's impact on postoperative D-lactic acid level | One month after surgery |
| D-lactic acid | Effect of enteral nutrition's impact on postoperative D-lactic acid level | Reaching full enteral feeding |
| Adiponectin | Effect of enteral nutrition's impact on postoperative Adiponectin level | One month after surgery |
| Adiponectin | Effect of enteral nutrition's impact on postoperative Adiponectin level | Reaching full enteral feeding |
| leptin | Effect of enteral nutrition's impact on postoperative leptin level | One month after surgery |
| leptin | Effect of enteral nutrition's impact on postoperative leptin level | Reaching full enteral feeding |
| Overall duration of parenteral nutrition | For patients who cannot obtain sufficient nutrition through enteral feeding for more than 5 days, consideration should be given to providing parenteral nutrition support | 4 weeks day after enteral feeding |