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Enteral Nutrition in Infants With Ileostomy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04707443
Enrollment
110
Registered
2021-01-13
Start date
2021-07-08
Completion date
2028-12-31
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition of Ileostomy Infants

Keywords

ileostomy, Human breast milk, Enteral nutrition, extensive hydrolyzed formula, amino acid formula

Brief summary

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

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.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Z-scores of body weight4 weeks after enteral feedingThe 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.

Secondary

MeasureTime frameDescription
Z-scores of body length4 weeks day after enteral feedingThe 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.
The change of ostomy volumeFrom the the day starting the enteral nutrition to the fourth week.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.
Z-scores of head circumference4 weeks day after enteral feedingZ-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Cholestasis4 weeks day after enteral feedingThe diagnostic criteria include the requirement of parenteral nutrition administration for a duration exceeding 2 weeks and an elevated direct bilirubin level \> 34 mmol/L
The incidence rate of septicemiaPrior to complete enteral nutritionThe impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of septicemia in pediatric patients following enterostomy
The incidence rate of colitisPrior to complete enteral nutritionThe impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of colitis in pediatric patients following enterostomy
D-lactic acidOne month after surgeryEffect of enteral nutrition's impact on postoperative D-lactic acid level
AdiponectinOne month after surgeryEffect of enteral nutrition's impact on postoperative Adiponectin level
leptinOne month after surgeryEffect of enteral nutrition's impact on postoperative leptin level
Overall duration of parenteral nutrition4 weeks day after enteral feedingFor patients who cannot obtain sufficient nutrition through enteral feeding for more than 5 days, consideration should be given to providing parenteral nutrition support

Countries

China

Contacts

CONTACTTian Qian, M.D.
drqiantian@fudan.edu.cn02164931981
CONTACTYiyao Zhou, Bachelor
kerry_zyy@yahoo.com02164931980
STUDY_DIRECTORTian Qian, M.D.

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026