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CompletedNCT04464057Updated Dec 13, 2022

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

An interventional study of early oral feeding or early enteral nurtrion in Enteral Feeding, Neonate and Infant, sponsored by Weibing Tang. Completed at 2 sites in China. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by Weibing Tang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
947
Allocation
Randomized
Ages
1 Day to 12 Months
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Enteral Feeding
  • Neonate
  • Infant
  • Intestinal Anastomosis Complication

Keywords

  • oral feeding
  • early enteral nurtrion
  • Intestinal anastomosis
  • neonate
  • infant
03

In context

Lead sponsor

Weibing Tang is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
947 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • Dietary supplementearly 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.

06

What researchers measure

Primary outcomes

  1. Anastomotic leakage or poor anastomotic healing

    Feces flow out from the site of the anastomosis into the abdominal cavity

    Time frame: 1-7days after early oral feeding

  2. Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.

    There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.

    Time frame: 1-14days after early oral feeding

  3. indexs of stress:C-reactive protein, interleukin 6, cortisol

    Some indexs could be defined as indicators of the severity of the stress response

    Time frame: The first day and third day after early oral feeding

  4. indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein

    Some indexs could be defined as indicators of the nutriton status

    Time frame: The seventh day after anastomosis

Secondary outcomes

  1. indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay

    Some indexs could be defined as indicators of recovery after surgery.

    Time frame: 1-14 days after surgery.

07

Study locations

2 sites
  • Anhui Provincial Children's Hispital
    Hefei, Anhui, China
  • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
    Xuzhou, Jiangsu 210000, China
08

References and documents

Study documents

  • Study protocol · Dec 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The data of the study would be shared with othe researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04464057
Lead sponsor
Weibing Tang
Responsible party
Weibing Tang (Chief of neonatal surgery department of Nanjing Children's Hospital, Nanjing Children's Hospital) — Sponsor-investigator
First posted
Jul 9, 2020
Start date
Aug 1, 2020
Primary completion
Aug 1, 2022
Completion
Aug 31, 2022
Last update
Dec 13, 2022

Study contacts

Weibing Tang, Dr
study director · Children's Hospital of Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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