The Effect of Early Enteral Feeding on Neonates After GIT Surgery

Post-Gastrointestinal Tract Surgery Malnutrition Clinical Trial

Official title:

The Effect of Early Enteral Feeding on Neonatal Outcome After Gastrointestinal Tract Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318353
• Other study ID #: EEF neonates after GIT surgery
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Sandy N Abaskharon, M.B.B.CH
• Phone: +2001285799882
• Email: sandinashat[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the effect of early vs late enteral feeding after abdominal surgery on neonatal outcome after surgery, weight gain, length of hospital stay, time to reach full enteral feeding, time to pass first stool, surgical site infections, sepsis and electrolyte disturbances.

Description:

There are a many reasons for gastrointestinal (GI) tract surgery and following surgery the aim is to efficiently establish infants on enteral feeds and wean them off of parenteral nutrition. Neonates may lose their body resources after surgery due to inadequate nutrient intake and undergoing long periods of fasting after surgery. Nil peroral (NPO)/nil by mouth has been the most commonly practiced convention in post-operative period. Misplaced fear of aspiration, prevent nausea, vomiting and anastomotic complications led to routine prescription of "NPO." The duration of postoperative fasting is variable but can range from 0 to 5 days depending on the operation. The ramifications of this period of fasting are not insignificant and may include prolonged length of stay, increased use of parenteral nutrition (PN), social effects and significant costs to the health system.

Starvation leads to disuse atrophy of villi, decrease disaccharide activity, decreased intestinal mucosa mass, and loss of DNA of enterocyte. This malfunctioning enterocyte leads to increase the permeability of intestinal mucosa to antigen and macromolecules. This starvation-induced gut mucosal injury leads to decrease the production of Vitamin K due to the absence of normal colonic flora. This also leads to decreased growth factors and bile acid metabolism. This compounded effect of starved gut and abnormal colonic bacterial environment leads to colonization of pathological bacteria and might lead to sepsis and sequelae. In addition, starvation leads to decreased immune cells of intestine gut-associated lymphoid tissue. This decreased gut immunity leads to increased uptake of toxins and decreased immune response to foreign antigen. This leads to bacterial translocation Traditionally after abdominal surgery, presence of bowel sounds or passage of flatus or stools has been the clinical evidence of restoration of bowel activity and indicators for starting oral diet. Bowel sounds are poor markers of bowel function as uncoordinated and antegrade peristalsis can be heard as bowel sounds. Currently, there is no good marker for return of bowel sounds, and even in the presence of prolonged ileus, the bowel moves .

Cochrane reviews have shown no advantage in keeping patients "nil by mouth" following gastrointestinal surgery and support early commencement of enteral feeding .

In neonates and infants there are additional issues with delayed feeding including cholestatic jaundice, sepsis, delayed gut development, and metabolic disease. Early trophic feeds may improve recovery time by increasing gut blood flow, improving motility and limiting the impact of starvation on the structure of the gut and its ability to absorb nutrients. Early introduction of enteral nutrition improves intestinal adaptation, reducing the risk of intestinal failure-associated liver disease (IFALD).

ESPEN guidelines recommend early initiation of enteral feeding within 24 h after gastrointestinal surgery, but also state that it needs to be adapted according to the individual tolerance and type of surgery .

So this study aims to evaluate the effect of early vs late enteral feeding after abdominal surgery on neonatal outcome after surgery, weight gain, length of hospital stay, time to reach full enteral feeding, time to pass first stool, surgical site infections, sepsis and electrolyte disturbances and will include all neonates who undergoing abdominal surgery and admitted in neonatal intensive care unit in Assiut University Children Hospital for one year.

The study will include 2 groups group A :start enteral feeding within 2 days postoperative and group B :start enteral feeding after 2 days postoperative according to clinician discretion based on clinical progress(ranging from 1-5 days after passage of flatus or stool.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• All admitted neonates who undergo abdominal surgery

Exclusion Criteria:

• Neonates with no-abdominal surgery.

• Neonates on mechanical ventilation

• Neonates with other co-morbidities like sepsis, severe respiratory distress, intracranial hemorrhage, birth asphyxia, congenital heart diseases and multiple congenital anomalies

Related Conditions & MeSH terms

• Malnutrition
• Post-Gastrointestinal Tract Surgery Malnutrition

Intervention

Other:
• early enteral feeding within 2 days postoperative
Enteral feeding within 2 days postoperative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Andersen HK, Lewis SJ, Thomas S. Early enteral nutrition within 24h of colorectal surgery versus later commencement of feeding for postoperative complications. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004080. Review. Update in: Cochrane Database Syst — View Citation

Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine), Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain	Follow up and record of weight after surgery every 24 hours and compaire the results between the two groups	One year
Secondary	Length of hospital stay	Record the length of hospital stay for each patient	One year
Secondary	Time to reach full enteral feeding	Record the time to reach full enteral feeding for each patient and compaire the average time between the 2 groups	One year
Secondary	Time to pass first stool	Record the time to pass first stool and compair the average time between the 2 groups	One year
Secondary	surgical site infections	Observe the patients for signs of surgical site infection and record the number of patients who has surgical site infection in the groups	One year
Secondary	sepsis	Observe the patients for signs of sepsis and record the number of patients who has sepsis in the groups	One year
Secondary	electrolyte disturbances	Electrolytes measurment is routinely done for each surgical patient we will record the result in our study and take the average for each group for comparison	One year

External Links

•   Early Enteral Feeding after Pediatric Abdominal Surgery: A Systematic Review of the Literature
•   Early enteral feeding following repair of gastroschisis is associated with shorter length of admission and better nutritional outcomes
•   Early Enteral Nutrition in Neonates Following Abdominal Surgery
•   Early feeding in tracheo esophageal fistula repair: Newer trends in post-operative care
•   Effects of Early Feeding Support on the Postoperative Weight Gain Status of Infants with Esophageal Atresia
•   Have you passed gas yet? Time for a new approach to feeding patients post operatively.
•   Neonatal feeding: care and outcomes following gastrointestinal surgery.
•   Postoperative Enteral Nutrition Guidelines Reduce the Risk of Intestinal Failure-Associated Liver Disease in Surgical Infants