The Effect of Early Enteral Feeding on Neonates After GIT Surgery

March 20, 2020 updated by: Sandy Nashat Rezk Abaskharon, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: One year
Record the length of hospital stay for each patient
One year
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
One year
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
One year
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
One year
sepsis
Time Frame: One year
Observe the patients for signs of sepsis and record the number of patients who has sepsis in the groups
One year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Azza A El Tayeb, MD, Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEF neonates after GIT surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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