Clinical trial NCT04707443: Enteral Nutrition in Infants With Ileostomy
Official title: Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutrition of Ileostomy Infants
Keywords: ileostomy
Human breast milk
Enteral nutrition
extensive hydrolyzed formula
amino acid formula
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 110
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants, undergo enterostomy for various reasons within the age range of 0-6 months

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.

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.

Primary outcomes:
measure: Z-scores of body weight
timeFrame: 4 weeks after enteral feeding
Secondary outcomes:
measure: Z-scores of body length
timeFrame: 4 weeks day after enteral feeding
measure: The change of ostomy volume
timeFrame: From the the day starting the enteral nutrition to the fourth week.
measure: Z-scores of head circumference
timeFrame: 4 weeks day after enteral feeding
measure: Cholestasis
timeFrame: 4 weeks day after enteral feeding
measure: The incidence rate of septicemia
timeFrame: Prior to complete enteral nutrition
measure: The incidence rate of colitis
timeFrame: Prior to complete enteral nutrition
measure: D-lactic acid
timeFrame: One month after surgery
measure: D-lactic acid
timeFrame: Reaching full enteral feeding
measure: Adiponectin
timeFrame: One month after surgery
measure: Adiponectin
timeFrame: Reaching full enteral feeding
measure: leptin
timeFrame: One month after surgery
measure: leptin
timeFrame: Reaching full enteral feeding
measure: Overall duration of parenteral nutrition
timeFrame: 4 weeks day after enteral feeding
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Tian Qian, M.D.
role: STUDY_DIRECTOR
References: