Enteral Nutrition in Infants With Ileostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nutrition of Ileostomy Infants. Basic parameters: up to 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy
Overview
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.
Primary outcome measures
- Z-scores of body weight [Time frame: 4 weeks after enteral feeding]
Secondary outcome measures (12)
- Z-scores of body length [Time frame: 4 weeks day after enteral feeding]
- The change of ostomy volume [Time frame: From the the day starting the enteral nutrition to the fourth week.]
- Z-scores of head circumference [Time frame: 4 weeks day after enteral feeding]
- Cholestasis [Time frame: 4 weeks day after enteral feeding]
- The incidence rate of septicemia [Time frame: Prior to complete enteral nutrition]
- The incidence rate of colitis [Time frame: Prior to complete enteral nutrition]
- D-lactic acid [Time frame: One month after surgery]
- D-lactic acid [Time frame: Reaching full enteral feeding]
- Adiponectin [Time frame: One month after surgery]
- Adiponectin [Time frame: Reaching full enteral feeding]
- leptin [Time frame: One month after surgery]
- leptin [Time frame: Reaching full enteral feeding]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT04707443 · (2020)288