Enteral Nutrition in Infants With Ileostomy
ConditionNutrition of Ileostomy Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorChildren's Hospital of Fudan University
About this trial
This study is a prospective, single center, practical, and observational open clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.
Disqualifiers
Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.
Trial population
Infants, undergo enterostomy for various reasons within the age range of 0-6 months
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
110 Participants
are grouped into 1 trial groupGroup A: enteral nutrition
Trial outcomes
Primary outcomes
1
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.
Time frame
4 weeks after enteral feedingSecondary outcomes
1
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.
Time frame
4 weeks day after enteral feeding2
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.
Time frame
From the the day starting the enteral nutrition to the fourth week.3
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time frame
4 weeks day after enteral feeding4
Cholestasis
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
Time frame
4 weeks day after enteral feedingSponsors and contacts
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Source ClinicalTrials.gov