Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2021-07-08
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Qian Tian
Deputy Director of clinical Nutrition
Principal Investigators
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Tian Qian, M.D.
Role: STUDY_DIRECTOR
Children's Hospital of Fudan University
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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(2020)288
Identifier Type: -
Identifier Source: org_study_id
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