Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants

December 10, 2022 updated by: Weibing Tang
The study is primary designed to evaluate the safety and effectiveness of early feeding after bowel anastomosis, and observe the effect of early postoperative feeding on promoting postoperative rehabilitation and reducing parenteral nutrition

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intestinal anastomosis is a common operation for the treatment of digestive tract diseases of newborns and infants. It is not be defined that when should begin oral feeding after intestinal anastomosis. Poor anastomotic healing or anastomotic leakage is the most serious complication after intestinal anastomosis, which often leads to severe abdominal infection, peritonitis and even death. Nowadays, it is believed that the causes of poor anastomotic healing or anastomotic leakage are various, including contaminated during the operation, the blood supplyment of the bowel edges at both ends of the anastomosis, anemia, anastomosis technique, type of surgery (selective or emergency), and anastomotic tension . The traditional view is that early feeding may increase the anastomotic tension, which may lead to poor anastomotic healing or leakage, so a lot of surgeons often take a fasting for 4-5 days after intestinal anastomosis to ensure good anastomotic healing, however there is no enough evidence for this view. On the contrary, the current research confirms that after intestinal anastomosis, under fasting conditions, the digestive system still has 1-2 liters of fluid through the anastomosis, so even if it is given postoperative oral feeding, It would not excessively increase the digestive fluid through the anastomosis. Obviously, the early guess that the anastomotic tension is increased is lacking in theoretical evidence. In recent years, with the in-depth study of intestinal function, intestinal mucosal barrier function and intestinal flora, early enteral nutrition has stretched more and more attention, which is believed could stimulate intestinal digestive fluid secretion, promote intestinal mucosal metabolism and repair, avoid intestinal villi atrophy, reduce intestinal bacterial translocation, promote intestinal function recovery and intestinal peristalsis. Postoperative intestinal obstruction is also an important reason for hindering early enteral nutrition, but current research believes that postoperative intestinal obstruction is often temporary, and in most cases will be relieved 4-8 hours after surgery. European Society of Parenteral Enteral Nutrition (ESPEN ) recommended that enteral nutrition should be performed within 24 hours after intestinal anastomosis, but it needs to be fully evaluated according to the children's own tolerance and the type of surgery. A large number of studies and meta-analysis have confirmed that early enteral nutrition is safe and feasible after intestinal anastomosis in adults, but there are still few studies in children, especially whether early enteral surgery can be performed after intestinal anastomosis is currently rarely reported in neonates and infants. This study evaluated the feasibility and effectiveness of early oral enteral nutrition in neonates and infants after intestinal anastomosis through a prospective study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
947

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Provincial Children's Hispital
    • Jiangsu
      • Xuzhou, Jiangsu, China, 210000
        • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1)neonates or infants less than 12 months (2)Intestinal anastomosis, including small intestine and colon anastomosis

Exclusion Criteria:

  • (1) Premature infants or children with a weight of less than 2.5 kg during surgery are excluded (2) Exclude cases of severe abdominal infection (3) Exclude cases of severe imbalance of the proximal and distal intestinal canal of the anastomosis (such as intestinal atresia)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
The patients in the experimental group would be given early oral feeding within 24-48 hours after intestinal anastomosis. Start taking it at 24-48 hours after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.
Dietary supplement: early oral feeding or early enteral nurtrion
The patients in the experimental group were fed orally within 24-48 hours after intestinal anastomosis. Start taking it at 24-48 hours after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.
No Intervention: control group
The control group would be given early oral feeding within 4-5 days after intestinal anastomosis. Start taking it at 4-5 days after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anastomotic leakage or poor anastomotic healing
Time Frame: 1-7days after early oral feeding
Feces flow out from the site of the anastomosis into the abdominal cavity
1-7days after early oral feeding
Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.
Time Frame: 1-14days after early oral feeding
There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.
1-14days after early oral feeding
indexs of stress:C-reactive protein, interleukin 6, cortisol
Time Frame: The first day and third day after early oral feeding
Some indexs could be defined as indicators of the severity of the stress response
The first day and third day after early oral feeding
indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein
Time Frame: The seventh day after anastomosis
Some indexs could be defined as indicators of the nutriton status
The seventh day after anastomosis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay
Time Frame: 1-14 days after surgery.
Some indexs could be defined as indicators of recovery after surgery.
1-14 days after surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weibing Tang

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NanjingCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data of the study would be shared with othe researchers.

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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