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Clinical Trials/NCT04707443
NCT04707443
Recruiting
Not Applicable

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

Children's Hospital of Fudan University1 site in 1 country110 target enrollmentJuly 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition of Ileostomy Infants
Sponsor
Children's Hospital of Fudan University
Enrollment
110
Locations
1
Primary Endpoint
Z-scores of body weight
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2021
End Date
January 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qian Tian

Deputy Director of clinical Nutrition

Children's Hospital of Fudan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Z-scores of body weight

Time Frame: 4 weeks after enteral feeding

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.

Secondary Outcomes

  • The incidence rate of septicemia(Prior to complete enteral nutrition)
  • Z-scores of body length(4 weeks day after enteral feeding)
  • Overall duration of parenteral nutrition(4 weeks day after enteral feeding)
  • The change of ostomy volume(From the the day starting the enteral nutrition to the fourth week.)
  • Z-scores of head circumference(4 weeks day after enteral feeding)
  • The incidence rate of colitis(Prior to complete enteral nutrition)
  • Cholestasis(4 weeks day after enteral feeding)
  • leptin(Reaching full enteral feeding)
  • D-lactic acid(Reaching full enteral feeding)
  • Adiponectin(Reaching full enteral feeding)

Study Sites (1)

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