Enteral Nutrition in Infants With Ileostomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Nutrition of Ileostomy Infants
• Intervention / Treatment: Other: donor human milk; Other: extensively hydrolyzed formula

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yiyao Zhou, Bachelor; Phone Number: 02164931980; Email: kerry_zyy@yahoo.com
• Study Contact Backup: Name: Tian Qian, M.D.; Phone Number: 02164931981; Email: drqiantian@fudan.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Yiyao Zhou, Bachelor; Phone Number: 02164931980; Email: kerry_zyy@yahoo.com
      • Contact: Tian Qian, M.d; Phone Number: 02164931981; Email: drqiantian@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants, undergo enterostomy for various reasons within the age range of 0-6 months

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Tian Qian, M.D., Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ileostomy; Enteral nutrition; amino acid formula; Human breast milk; extensive hydrolyzed formula
• Other Study ID Numbers: (2020)288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No