<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464057</url>
  </required_header>
  <id_info>
    <org_study_id>NanjingCH</org_study_id>
    <nct_id>NCT04464057</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants</brief_title>
  <official_title>Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weibing Tang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Children's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is primary designed to evaluate the safety and effectiveness of early feeding after&#xD;
      bowel anastomosis, and observe the effect of early postoperative feeding on promoting&#xD;
      postoperative rehabilitation and reducing parenteral nutrition&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intestinal anastomosis is a common operation for the treatment of digestive tract diseases of&#xD;
      newborns and infants. It is not be defined that when should begin oral feeding after&#xD;
      intestinal anastomosis. Poor anastomotic healing or anastomotic leakage is the most serious&#xD;
      complication after intestinal anastomosis, which often leads to severe abdominal infection,&#xD;
      peritonitis and even death. Nowadays, it is believed that the causes of poor anastomotic&#xD;
      healing or anastomotic leakage are various, including contaminated during the operation, the&#xD;
      blood supplyment of the bowel edges at both ends of the anastomosis, anemia, anastomosis&#xD;
      technique, type of surgery (selective or emergency), and anastomotic tension . The&#xD;
      traditional view is that early feeding may increase the anastomotic tension, which may lead&#xD;
      to poor anastomotic healing or leakage, so a lot of surgeons often take a fasting for 4-5&#xD;
      days after intestinal anastomosis to ensure good anastomotic healing, however there is no&#xD;
      enough evidence for this view. On the contrary, the current research confirms that after&#xD;
      intestinal anastomosis, under fasting conditions, the digestive system still has 1-2 liters&#xD;
      of fluid through the anastomosis, so even if it is given postoperative oral feeding, It would&#xD;
      not excessively increase the digestive fluid through the anastomosis. Obviously, the early&#xD;
      guess that the anastomotic tension is increased is lacking in theoretical evidence. In recent&#xD;
      years, with the in-depth study of intestinal function, intestinal mucosal barrier function&#xD;
      and intestinal flora, early enteral nutrition has stretched more and more attention, which is&#xD;
      believed could stimulate intestinal digestive fluid secretion, promote intestinal mucosal&#xD;
      metabolism and repair, avoid intestinal villi atrophy, reduce intestinal bacterial&#xD;
      translocation, promote intestinal function recovery and intestinal peristalsis. Postoperative&#xD;
      intestinal obstruction is also an important reason for hindering early enteral nutrition, but&#xD;
      current research believes that postoperative intestinal obstruction is often temporary, and&#xD;
      in most cases will be relieved 4-8 hours after surgery. European Society of Parenteral&#xD;
      Enteral Nutrition (ESPEN ) recommended that enteral nutrition should be performed within 24&#xD;
      hours after intestinal anastomosis, but it needs to be fully evaluated according to the&#xD;
      children's own tolerance and the type of surgery. A large number of studies and meta-analysis&#xD;
      have confirmed that early enteral nutrition is safe and feasible after intestinal anastomosis&#xD;
      in adults, but there are still few studies in children, especially whether early enteral&#xD;
      surgery can be performed after intestinal anastomosis is currently rarely reported in&#xD;
      neonates and infants. This study evaluated the feasibility and effectiveness of early oral&#xD;
      enteral nutrition in neonates and infants after intestinal anastomosis through a prospective&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a prospective, randomized controlled clinical study. A total of 285 inpatients (95 experimental groups and 190 control groups) were enrolled to evaluate the safety and effectiveness of early feeding in neonates and infants after intestinal anastomosis</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>According to age and disease, the first pairing design, three pairs (experimental group: control group = 1:2), after pairing three subjects randomly assigned to the experimental group, the other two to the control group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Anastomotic leakage or poor anastomotic healing</measure>
    <time_frame>1-7days after early oral feeding</time_frame>
    <description>Feces flow out from the site of the anastomosis into the abdominal cavity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.</measure>
    <time_frame>1-14days after early oral feeding</time_frame>
    <description>There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>indexs of stress:C-reactive protein, interleukin 6, cortisol</measure>
    <time_frame>The first day and third day after early oral feeding</time_frame>
    <description>Some indexs could be defined as indicators of the severity of the stress response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein</measure>
    <time_frame>The seventh day after anastomosis</time_frame>
    <description>Some indexs could be defined as indicators of the nutriton status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay</measure>
    <time_frame>1-14 days after surgery.</time_frame>
    <description>Some indexs could be defined as indicators of recovery after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">947</enrollment>
  <condition>Enteral Feeding</condition>
  <condition>Neonate</condition>
  <condition>Infant</condition>
  <condition>Intestinal Anastomosis Complication</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>early oral feeding or early enteral nurtrion</intervention_name>
    <description>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.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1)neonates or infants less than 12 months (2)Intestinal anastomosis, including small&#xD;
             intestine and colon anastomosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Premature infants or children with a weight of less than 2.5 kg during surgery are&#xD;
             excluded (2) Exclude cases of severe abdominal infection (3) Exclude cases of severe&#xD;
             imbalance of the proximal and distal intestinal canal of the anastomosis (such as&#xD;
             intestinal atresia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weibing Tang, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Children's Hospital of Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Provincial Children's Hispital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>December 10, 2022</last_update_submitted>
  <last_update_submitted_qc>December 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Children's Hospital</investigator_affiliation>
    <investigator_full_name>Weibing Tang</investigator_full_name>
    <investigator_title>Chief of neonatal surgery department of Nanjing Children's Hospital</investigator_title>
  </responsible_party>
  <keyword>oral feeding</keyword>
  <keyword>early enteral nurtrion</keyword>
  <keyword>Intestinal anastomosis</keyword>
  <keyword>neonate</keyword>
  <keyword>infant</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data of the study would be shared with othe researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 9, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT04464057/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464057
org study id: NanjingCH
nct id: NCT04464057
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a prospective, randomized controlled clinical study. A total of 285 inpatients (95 experimental groups and 190 control groups) were enrolled to evaluate the safety and effectiveness of early feeding in neonates and infants after intestinal anastomosis
primary purpose: Treatment
masking: Single (Participant)
masking description: According to age and disease, the first pairing design, three pairs (experimental group: control group = 1:2), after pairing three subjects randomly assigned to the experimental group, the other two to the control group
measure: Anastomotic leakage or poor anastomotic healing
time frame: 1-7days after early oral feeding
description: Feces flow out from the site of the anastomosis into the abdominal cavity
measure: Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.
time frame: 1-14days after early oral feeding
description: There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.
measure: indexs of stress:C-reactive protein, interleukin 6, cortisol
time frame: The first day and third day after early oral feeding
description: Some indexs could be defined as indicators of the severity of the stress response
measure: indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein
time frame: The seventh day after anastomosis
description: Some indexs could be defined as indicators of the nutriton status
measure: 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.
description: Some indexs could be defined as indicators of recovery after surgery.
arm group label: experimental group
arm group type: Experimental
description: 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.
arm group label: control group
arm group type: No Intervention
description: 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.
intervention type: Dietary Supplement
intervention name: early oral feeding or early enteral nurtrion
description: 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.
arm group label: experimental group
criteria: 
gender: All
minimum age: 1 Day
maximum age: 12 Months
healthy volunteers: No
last name: Weibing Tang, Dr
role: Study Director
affiliation: Children's Hospital of Nanjing Medical University
facility: 
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Nanjing Children's Hospital
investigator full name: Weibing Tang
investigator title: Chief of neonatal surgery department of Nanjing Children's Hospital
sharing ipd: No
ipd description: The data of the study would be shared with othe researchers.
provided document: 