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

NCT04464057 | Completed

• 1 other identifier: NanjingCH
• Study Type: interventional
• Target: 947
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Enteral Feeding; Neonate; Infant; Intestinal Anastomosis Complication

Keywords

oral feeding; early enteral nurtrion; Intestinal anastomosis; neonate; infant

Outcome Measures

Primary Outcomes (4)

• Anastomotic leakage or poor anastomotic healing

  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.

  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

  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

  Some indexs could be defined as indicators of the nutriton status

  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

  1-14 days after surgery.

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

early oral feeding or early enteral nurtrion DIETARY_SUPPLEMENT

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.

experimental group

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Weibing Tang: lead

Study Sites (2)

Anhui Provincial Children's Hispital

Hefei, Anhui, China

Location

Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College

Xuzhou, Jiangsu, 210000, China

Location

Related Publications (1)

• Lu C, Sun X, Geng Q, Tang W. Early oral feeding following intestinal anastomosis surgery in infants: a multicenter real world study. Front Nutr. 2023 Jul 20;10:1185876. doi: 10.3389/fnut.2023.1185876. eCollection 2023.

  PMID: 37545580 DERIVED

Study Officials

• Weibing Tang, Dr

  Children's Hospital of Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of neonatal surgery department of Nanjing Children's Hospital

Model Details: 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

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 31, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)