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NCT Number: NCT04707443

Enteral Nutrition in Infants With Ileostomy

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

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Z-scores of body length

    Time frame: 4 weeks day after enteral feeding

    The 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.

  2. The change of ostomy volume

    Time frame: From 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.

  3. Z-scores of head circumference

    Time frame: 4 weeks day after enteral feeding

    Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.

  4. Cholestasis

    Time frame: 4 weeks day after enteral feeding

    The diagnostic criteria include the requirement of parenteral nutrition administration for a duration exceeding 2 weeks and an elevated direct bilirubin level > 34 mmol/L

  5. The incidence rate of septicemia

    Time frame: Prior to complete enteral nutrition

    The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of septicemia in pediatric patients following enterostomy

  6. The incidence rate of colitis

    Time frame: Prior to complete enteral nutrition

    The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of colitis in pediatric patients following enterostomy

  7. D-lactic acid

    Time frame: One month after surgery

    Effect of enteral nutrition's impact on postoperative D-lactic acid level

  8. D-lactic acid

    Time frame: Reaching full enteral feeding

    Effect of enteral nutrition's impact on postoperative D-lactic acid level

  9. Adiponectin

    Time frame: One month after surgery

    Effect of enteral nutrition's impact on postoperative Adiponectin level

  10. Adiponectin

    Time frame: Reaching full enteral feeding

    Effect of enteral nutrition's impact on postoperative Adiponectin level

  11. leptin

    Time frame: One month after surgery

    Effect of enteral nutrition's impact on postoperative leptin level

  12. leptin

    Time frame: Reaching full enteral feeding

    Effect of enteral nutrition's impact on postoperative leptin level

  13. Overall duration of parenteral nutrition

    Time frame: 4 weeks day after enteral feeding

    For patients who cannot obtain sufficient nutrition through enteral feeding for more than 5 days, consideration should be given to providing parenteral nutrition support

Study contacts

Contact information is provided by the study sponsor or research team.

Tian Qian, M.D.

CONTACT

[email protected]

02164931981

Yiyao Zhou, Bachelor

CONTACT

[email protected]

02164931980

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jan 13, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.