Enteral Nutrition in Infants With Ileostomy

Nutrition of Ileostomy Infants Clinical Trial

Official title:

Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707443
• Other study ID #: (2020)288
• Status: Recruiting
• Start date: July 8, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: Children's Hospital of Fudan University
• Contact: Tian Qian, M.D.
• Phone: 02164931981
• Email: drqiantian[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective, single center, practical, and observational open clinical study.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.

Exclusion Criteria:

• Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.

Related Conditions & MeSH terms

• Nutrition of Ileostomy Infants

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The change of ostomy volume	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	D-lactic acid	Effect of enteral nutrition's impact on postoperative D-lactic acid level	One month after surgery
Secondary	D-lactic acid	Effect of enteral nutrition's impact on postoperative D-lactic acid level	Reaching full enteral feeding
Secondary	Adiponectin	Effect of enteral nutrition's impact on postoperative Adiponectin level	One month after surgery
Secondary	Adiponectin	Effect of enteral nutrition's impact on postoperative Adiponectin level	Reaching full enteral feeding
Secondary	leptin	Effect of enteral nutrition's impact on postoperative leptin level	One month after surgery
Secondary	leptin	Effect of enteral nutrition's impact on postoperative leptin level	Reaching full enteral feeding
Secondary	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