Enteral FeedingNCT04464057
Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
A study testing early oral feeding or early enteral nurtrion in people with Enteral Feeding and Neonate, run by Weibing Tang at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Enteral Feeding, Neonate, Infant
- What is being tested?
- early oral feeding or early enteral nurtrion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 947 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2020to 31 Aug 2022
- Phase
- Interventional
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (1)neonates or infants less than 12 months (2)Intestinal anastomosis, including small intestine and colon anastomosis
Who cannot join
- (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)
Trial locations and contacts
2 sites in 1 country.
China2 sites
Anhui Provincial Children's Hispital
Hefei, Anhui
Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
Xuzhou, Jiangsu, 210000
About this study
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.
- Conditions
- Enteral Feeding, Neonate, Infant, Intestinal Anastomosis Complication
- Being tested
- early oral feeding or early enteral nurtrion
- Keywords
- oral feeding, early enteral nurtrion, Intestinal anastomosis, neonate, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early oral feeding or early enteral nurtrionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage or poor anastomotic healing
Feces flow out from the site of the anastomosis into the abdominal cavity
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 1-14 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weibing Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Weibing Tang, Dr, Study director, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464057
- Sponsor's protocol ID
- NanjingCH
- Status last verified
- Dec 2022
- First submitted
- 6 Jul 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study would be shared with othe researchers.
Publications
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.
PubMed 37545580
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
- ClinicalTrials.gov ID
- NCT04464057
- Acronym / sponsor ID
- NanjingCH
- Conditions
- Enteral Feeding, Neonate, Infant, Intestinal Anastomosis Complication
- Keywords
- oral feeding, early enteral nurtrion, Intestinal anastomosis, neonate, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- Weibing TangUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: early oral feeding or early enteral nurtrionThe 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. |
| 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. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (1)neonates or infants less than 12 months (2)Intestinal anastomosis, including small intestine and colon anastomosis
Key exclusion criteria (1 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early oral feeding or early enteral nurtrionThe 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. | Dietary supplement | experimental group |
Primary outcome
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
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.
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
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 37545580Lu 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.
- Individual participant dataSharing planned: No. The data of the study would be shared with othe researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Tang, Dr study director
Children's Hospital of Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early oral feeding or early enteral nurtrion in people with Enteral Feeding and Neonate, run by Weibing Tang at 2 sites in China.
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 1 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: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage or poor anastomotic healing (time frame: 1-7days after early oral feeding). The study lists 4 primary outcomes in all. 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 NCT04464057, which also lists 1 linked publication.
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 13 Dec 2022.