Enteral Nutrition in Infants With Ileostomy

Study Overview
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Brief Summary
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This study is a prospective, single-center, practical, randomized controlled, parallel and open clinical study.

Detailed Description
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A total of 112 non-breastfed infants with ileostomy who are prepared for enteral nutrition will be enrolled. They will be randomly divided into donor milk group and extensively hydrolyzed formula group. To investigate the effects of different enteral nutrients on the growth and development of infants with ileostomy, evaluate and compare the effectiveness of extensively hydrolyzed formula and donor human milk, and the effects on postoperative intestinal permeability, ostomy fluid volume, intestinal microbiome and metabolites, septicemia, colitis and cholestasis.

Official Title
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Prognosis of Donor Human Milk and Extensive Hydrolyzed Formula in Infants With Ileostomy

Conditions
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Nutrition of Ileostomy Infants

Intervention / Treatment
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* Other: donor human milk
* Other: extensively hydrolyzed formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 112 non-breastfed inpatients who are prepared for enteral nutrition after small intestinal fistula will be enrolled. They will be randomly divided into donor milk group and extensively hydrolyzed formula group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: donor human milk<br>For patients who can be fed orally or through tubes after surgery, donor milk will be used to feeding for 4 weeks. | Other: donor human milk<br>* Donor human milk: from our center's milk bank Starting dose: 10-20 ml/kg/day (specific according to the amount of fistula or excrement). Evaluate twice every 24 hours, observe for at least 24 hours before volume advancement. Target dose: 150mL/kg/d (energy: 100 to 140 kcal/kg/d). Duration: from the first day when the patient start enteral feeding to the 28th day, lasting for four weeks.<br>|
| Active Comparator: extensively hydrolyzed formula<br>For patients who can be fed orally or through tubes after surgery, extensively hydrolyzed formula will be used to feeding for 4 weeks. | Other: extensively hydrolyzed formula<br>* eHF：commercial formulation, distribution from enteral nutrition preparation room of our center Starting dose: 10-20 ml/kg/day (specific according to the amount of fistula or excrement). Evaluate twice every 24 hours, observe for at least 24 hours before volume advancement. Target dose: 150mL/kg/d (energy: 100 to 140 kcal/kg/d). Duration: from the first day when the patient start enteral feeding to the 28th day, lasting for four weeks.<br>* Other names: eHF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-scores of body weight | 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. | 4 weeks after enteral feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-scores of body length | 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. | 4 weeks day after enteral feeding | 
| The change of ostomy volume | 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. | From the the day starting the enteral nutrition to the forth week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, Enteral Nutrition, Donor human Milk, extensively hydrolyzed formula