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The Effect of Early Enteral Feeding on Neonates After GIT Surgery

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ClinicalTrials.gov Identifier: NCT04318353
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sandy Nashat Rezk Abaskharon, Assiut University

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.

Condition or disease Intervention/treatment
Post-Gastrointestinal Tract Surgery Malnutrition Other: early enteral feeding within 2 days postoperative

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Early Enteral Feeding on Neonatal Outcome After Gastrointestinal Tract Surgery
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Group/Cohort Intervention/treatment
early enteral feeding
start enteral feeding within 2 days postoperative
Other: early enteral feeding within 2 days postoperative
Enteral feeding within 2 days postoperative

control
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.



Primary Outcome Measures :
  1. weight gain [ Time Frame: One year ]
    Follow up and record of weight after surgery every 24 hours and compaire the results between the two groups


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: One year ]
    Record the length of hospital stay for each patient

  2. Time to reach full enteral feeding [ Time Frame: One year ]
    Record the time to reach full enteral feeding for each patient and compaire the average time between the 2 groups

  3. Time to pass first stool [ Time Frame: One year ]
    Record the time to pass first stool and compair the average time between the 2 groups

  4. surgical site infections [ Time Frame: One year ]
    Observe the patients for signs of surgical site infection and record the number of patients who has surgical site infection in the groups

  5. sepsis [ Time Frame: One year ]
    Observe the patients for signs of sepsis and record the number of patients who has sepsis in the groups

  6. electrolyte disturbances [ Time Frame: One year ]
    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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318353


Contacts
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Contact: Sandy N Abaskharon, M.B.B.CH +2001285799882 sandinashat@yahoo.com
Contact: Safwat M Abdel-Aziz, MD

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Azza A El Tayeb, MD Assiut University
Additional Information:
Publications of Results:
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Responsible Party: Sandy Nashat Rezk Abaskharon, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04318353    
Other Study ID Numbers: EEF neonates after GIT surgery
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandy Nashat Rezk Abaskharon, Assiut University:
neonatal feeding
gastrointestinal tract surgery
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders