Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
Location status: Recruiting
Location contact
Tian Qian, M.d
CONTACT
Yiyao Zhou, Bachelor
CONTACT
NCT Number: NCT04707443
This study is a prospective, single center, practical, and observational open clinical study.
Interested in participating?
Request InfoUp to 6 month
All sexes
Observational
Shanghai, Shanghai Municipality, 200000, China
Location status: Recruiting
Tian Qian, M.d
CONTACT
Yiyao Zhou, Bachelor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 4 weeks day after enteral feeding
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
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
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
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
Time frame: One month after surgery
Effect of enteral nutrition's impact on postoperative D-lactic acid level
Time frame: Reaching full enteral feeding
Effect of enteral nutrition's impact on postoperative D-lactic acid level
Time frame: One month after surgery
Effect of enteral nutrition's impact on postoperative Adiponectin level
Time frame: Reaching full enteral feeding
Effect of enteral nutrition's impact on postoperative Adiponectin level
Time frame: One month after surgery
Effect of enteral nutrition's impact on postoperative leptin level
Time frame: Reaching full enteral feeding
Effect of enteral nutrition's impact on postoperative leptin level
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
Contact information is provided by the study sponsor or research team.
Tian Qian, M.D.
CONTACT
Yiyao Zhou, Bachelor
CONTACT
Children's Hospital of Fudan University
Other
Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy
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.