Clinical trial NCT04318353: The Effect of Early Enteral Feeding on Neonates After GIT Surgery
Official title: The Effect of Early Enteral Feeding on Neonatal Outcome After Gastrointestinal Tract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-Gastrointestinal Tract Surgery Malnutrition
Keywords: neonatal feeding
gastrointestinal tract surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all neonates who undergoing abdominal surgery and admitted in neonatal intensive care unit in Assiut University Children Hospital for one year

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: weight gain
timeFrame: One year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: One year
measure: Time to reach full enteral feeding
timeFrame: One year
measure: Time to pass first stool
timeFrame: One year
measure: surgical site infections
timeFrame: One year
measure: sepsis
timeFrame: One year
measure: electrolyte disturbances
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Azza A El Tayeb, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/14651858.CD004080.pub2.
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 Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.