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Post-Gastrointestinal Tract Surgery MalnutritionNCT04318353

The Effect of Early Enteral Feeding on Neonates After GIT Surgery

An observational study of Post-Gastrointestinal Tract Surgery Malnutrition, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 1 day to 28 days
What is being tested?
early enteral feeding within 2 days postoperative
How many people
150 participants
Where
No sites listed yet
Study dates
Jan 2021to Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: all neonates who undergoing abdominal surgery and admitted in neonatal intensive care unit in Assiut University Children Hospital for one year

Who may be able to join

  • All admitted neonates who undergo abdominal surgery

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Sandy N Abaskharon, M.B.B.CH contact

+2001285799882

sandinashat@yahoo.com

Safwat M Abdel-Aziz, MD contact

About this study

Official title: 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.

Read the 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.

Being tested
early enteral feeding within 2 days postoperative
Keywords
neonatal feeding, gastrointestinal tract surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early enteral feeding within 2 days postoperativeOther

    Enteral feeding within 2 days postoperative

Study groups in NCT04318353
Study groupRoleWhat they receive
early enteral feedingstart enteral feeding within 2 days postoperative
Receives: Other: early enteral feeding within 2 days postoperative
controlstart 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. weight gain

    Follow up and record of weight after surgery every 24 hours and compaire the results between the two groups

    Measured: One year

Secondary outcomes (6)
  1. Length of hospital stay

    Record the length of hospital stay for each patient

    Measured: One year

  2. 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

    Measured: One year

  3. Time to pass first stool

    Record the time to pass first stool and compair the average time between the 2 groups

    Measured: One year

  4. 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

    Measured: One year

  5. sepsis

    Observe the patients for signs of sepsis and record the number of patients who has sepsis in the groups

    Measured: One year

  6. 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

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study startJan 2021 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318353
Sponsor's protocol ID
EEF neonates after GIT surgery
Status last verified
Mar 2020
First submitted
19 Mar 2020
Last updated
23 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17054196
  • 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.

    PubMed 16698152

Questions about this trial

What is this clinical trial studying?

An observational study of Post-Gastrointestinal Tract Surgery Malnutrition, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sandy N Abaskharon, M.B.B.CH (+2001285799882, sandinashat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight gain (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04318353, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.

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