Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
Phase: NA
Conditions: Enteral Feeding, Neonate, Infant, Intestinal Anastomosis Complication
Sponsor: Weibing Tang

Official title:Safety and Effectiveness of Early Feeding After Bowel
Anastomosis in Neonates or Infants
NCT：04464057(This study was registered on Clinical Trials. gov )
Primary Completion Date：2022-12-09
A multi-center cohort was established in August 2020,and 941 case records were uploaded to
http://212.64.50.165 at discharge from hospital.
The 1st part:Safety and Effectiveness of Early Feeding After Bowel
Anastomosis in upper,middle and lower intestinal events
Absract:
Purpose In order to prevent postoperative complications, delayed oral feeding(DOF) was still a
common model of care following pediatric intestinal anastomosis surgery; however, early oral
feeding(EOF) has been proven to be safe and effective in reducing the incidence of complications
and fast recovery after some pediatric intestinal anastomosis. Unfortunately, evidence for initiating
EOF after intestinal anastomosis in infants is insufficient. Hence, this study was primarily
designed to evaluate the safety and efficacy of EOF in infants with intestinal anastomosis.
Methods 568 infants from the multi-center cohort were divided into three types of intestinal
anastomosis: duodenal anastomosis (EOF group,n=15; DOF group,n=67), jejunal anastomosis
(EOF group,n=56;DOF group,n=155), and ileal/colonic anastomosis(EOF group,n=61;DOF
group,n=214). The incidence of complications and the indexes of recovery were compared
between the EOF and DOF groups in the three types of anastomosis independently.
Results Parenteral nutrition(PN) time and postoperative hospital stay were significantly shorter in
EOF group than that in DOF group(Duodenal anastomosis:9.00[6.00,10.00] d vs 12.00[8.00,16.00]
d,p=-0.033;10.00[7.00,13.00]
d
vs
14.00[11.00,18.00]
d,p=0.002;Jejunal
anastomosis:7.00[6.00,8.00]
d
vs
9.00[7.00,13.00]
d,p<0.001;13.00[9.00,14.00]
d
vs
15.00[12.00,17.00] d,p<0.001;Ileal/colonic anastomosis:6.00[5.00,7.00] d vs 8.00[6.00,10.00]
d,p<0.001;7.00[6.00,10.50] d vs 10.00[8.00,13.00] d,p<0.001). There were no differences in terms
of abdominal distension,vomiting,diarrhea,weight change,serum albumin change,white blood
cell(WBC) count,and C reaction protein(CRP) level at discharge between the EOF and DOF
groups in the three types of anastomosis (all p>0.05).No hematochezia or anastomotic leakage
were found.
Statistical analysis
Data were presented as percentages, medians, or averages, and the level of statistical significance
was set at 0.05. SPSS 23.0 was used for statistical analysis, and the distribution of continuous
variables was examined for normality. A t-test was applied for normally distributed data, and a
rank-sum test was performed for non-normally distributed data. Categorical variables were tested
using the chi-squared or Fisher’s exact test.

Results :
EOF in the three types of intestinal anastomosis in neonates and infants
The types of intestinal
anastomosis
EOF
[n(%)]
DOF
[n(%)]
Chi-square test
2
P
Duodenum(n=85)
16(18.8%)
69(81.2%)
6.657
0.036
Jejunum(n=211)
60(28.2%)
153(71.8%)
ileum/colon(n=275)
68(19.3.2%)
284(80.7%)
Total(n=568)
144(23.2%)
506(76.8)
-
-
Complications of EOF in the three types of intestinal anastomosis
There were no hematochezia and anastomotic leakage in all types of intestinal anastomosis.
Complications of EOF in the three types of intestinal anastomosis
Complications
Abdominal
distension
vomit
diarrhea
overall
complication
Duodenal
anastomosis
EOF(n=15)
4(26.7%)
4(26.7%)
1(6.7%)
7(46.7%)
DOF(n=67)
13(19.4%)
10(14.9%)
3(4.5%)
22(32.8%)
P
0.501
0.275
0.562
0.375
Jejunal
anastomosis
EOF(n=56)
0(0.0%)
4(7.1%)
-
4(7.1%)
DOF(n=155)
8(5.2%)
3(1.9%)
-
11(7.1%)
P
0.113
0.082
-
1.000
Ileal/Colonic
anastomosis
EOF(n=61)
4(6.6%)
3(4.9%
1(1.6%
7(11.5%)
DOF(n=214)
6(2.8%)
3(1.4%)
2(0.9%)
9(4.2%)
p
0.236
0.125
0.530
0.056
Complications
Abdominal
distension
vomit
diarrhea
overall
complication
Duodenal
anastomosis
EOF(n=15)
4(26.7%)
4(26.7%)
1(6.7%)
7(46.7%)
DOF(n=67)
13(19.4%)
10(14.9%)
3(4.5%)
22(32.8%)
P
0.501
0.275
0.562
0.375
Jejunal
anastomosis
EOF(n=56)
0(0.0%)
4(7.1%)
-
4(7.1%)
DOF(n=155)
8(5.2%)
3(1.9%)
-
11(7.1%)
P
0.113
0.082
-
1.000

There were no hematochezia and anastomotic leakage in all types of intestinal anastomosis.
Study Design:
2.The 2st part:Early oral feeding enhanced recovery after intestinal
anastomosis in neonates and young infants less than 3 months old
Abstract:
Purpose Early oral feeding(EOF) has been proven with a low incidence of complications and fast
recovery after surgery in some elective pediatric patients,however,evidence for initiating EOF
after intestinal anastomosis(IA) in neonates and young infants,with immature immune system and
organs, is insufficient.This tudy was primary designed to investigate the status and evaluate the
feasibility of EOF in neonates and young infants with IA in mainland china. Method 491 neonates
and young infants from 51 hospital in china mainland were divided into two groups(EOF
Ileal/Colonic
anastomosis
EOF(n=61)
4(6.6%)
3(4.9%
1(1.6%
7(11.5%)
DOF(n=214)
6(2.8%)
3(1.4%)
2(0.9%)
9(4.2%)
p
0.236
0.125
0.530
0.056

group,n=88;traditional oral feeding,TOF group,n=403),and the clinical characteristics were
collected and analyzed for evaluation of the status of EOF in neonates and young infants.The
complications and recovery were also be compared to defined the feasibility after balancing the
baseline by propensity score matching(PSM).Result The time of TPN,PN and postoperative
hospital stay were significantly shorter in the EOF group than that in the TOF group in neonates
and young infants with IA(2.00[1.00,2.00]d vs. 5.00[3.00,6.00]d, p<0.001; 7.00[5.00,8.00]d
vs.9.00[7.00,13.00]d, p<0.001;11.00[8.00,14.00]]d vs.14.00[11.00,17.00]d).There were significant
differences in the spectrum of disorders, anastomotic sites,operative age and weight between EOF
and TOF groups(p=0.002;p=0.029,p=0.045,p<0.001).The overall low rate of EOF in neonates and
infants with
IA was 17.9%,especially lower
in intestinal
atresia,stenosis,stoma closure,
ileal-colonic,colonic anastomotic site,operative age less than 30 days and weight less
than 2.5kg.The overall rate of and Clavien-Dindo II complications were higher in EOF
than
TOF
group(p=0.002),however,no
differences
were
found
in
severe
complications(Clavien-Dindo III/ IV/V).Conclusion The rate of EOF in neonates and young
infants with IA is low in Mainland China and the spectrum of disorders,anastomotic
sites,operative age and weight maybe factors affecting the performing of EOF. Nevertheless,
implementing EOF in neonates and young infants with IA maybe beneficial, enhances the
recovery, and does not increase the rate of severe complications.
Keywords early oral feeding;intestinal anastomosis, neonate;young infant
Statistical analysis
Data were presented as percentages, medians, or averages, and the level of statistical
significance was set at 0.05. SPSS 22.0 was used for statistical analysis, and the distribution of
continuous variables was examined for normality. A t-test was applied for normally distributed
data, and a rank-sum test was performed for non-normally distributed data. Categorical variables
were tested using the chi-squared or Fisher’s exact test.Before comparing the complications and
recovery between EOF and TOF groups,a 1:2 propensity score match(PSM) with caliper 0.05 was
applied to balance the baseline data between the two groups.
Results:
Baseline clinical characteristics of neonates and young infants with intestinal anastomosis in EOF
and TOF groups

group
EOF
（n=88,%）
TOF
(n=403,%)
P
The
spectrum
of
disorders
Intestinal atresia(n=69)
5（5.7%）
64（15.9%）
0.002
intestinal mass(n=32)
4（6.9%）
28（4.5%）
intestinal necrosis(n=24)
3（5.2%）
21（3.4%）
intestinal stenosis(n=38)
3(3.4%)
35(8.7%)
biliary disease(n=178)
48(32.3%)
130(54.5%)
colsing the stoma(n=41)
4(4.5%)
37(9.2%)
patent vitelline duct(n=19)
6(n=3.2%)
13(6.8%)
duodenal obstruction(n=84)
15(17%)
69(17.1%)
adhesional obstruction(n=6)
0(0%)
6(1.5%)
Anastomic
sites
Duodenal anastomosis
（n=83）
15(17.0%)
68(16.9%)
0.029
Jejunal anastomosis(n=218)
50(56.8%)
168(41.7%)
Ileal anastomosis(n=123)
19(21.6%)
104(25.8%)
Ileal-colonic
anastomosis(n=36)
2(2.3%)
34（8.4%）
Colonic anastomosis(n=31)
2(2.3%)
29(7.2%)
Surgical
approach
laparoscope（n=132）
19(21.6%)
113(28.0%)
0.216
laparotomy(n=359)
69(78.4%)
290(72.0%)
gender
male(n=259)
46(52.37%)
213(52.9%)
0.921
female(n=232)
42(47.7%)
190(47.1%)
Operative age（d,Median[P25%,P75%]）
40[11,65]
34[4,58]
0.045
Operateive weight
（kg,Median[P25%,P75%]）
4.38[3.40,5.10]
3.58[2.8,4.5]
<0.00
1
Pre-operative
albumin(g/L,Median[P25%,P75%]）
37.10[34.63,40.
45]
36.30[33.10,39.7
0]
0.054
Pre-operative
prealbumin(g/L,Median[P25%,P75%]）
0.15[0.10,0.17]
0.13[0.09,0.16]
0.062

Baseline clinical characteristics of young infants with intestinal anastomosis in EOF and TOF
groups after PSM
group
EOF
（n=86,%）
TOF
(n=156,%)
P
The
spectrum
of
disorders
Intestinal atresia(n=15)
5(5.8%)
11(7.1%)
0.963
intestinal mass(n=15)
4(4.7%)
11(7.8%)
intestinal necrosis(n=9)
3(3.5%)
6(3.8%)
intestinal stenosis(n=11)
3(3.5%)
8(5.1%)
biliary disease(n=123)
46(53.5%)
77(49.4%)
colsing the stoma(n=13)
4(4.7%)
9(5.8%)
patent vitelline duct(n=13)
6(n=7.0%)
7(4.5%)
duodenal obstruction(n=42)
15(17.4%)
27(17.3%)
Anastomic
sites
Duodenal anastomosis
（n=42）
15(17.4%)
27(17.3%)
0.927
Jejunal anastomosis(n=130)
48(55.8%)
82(52.6%)
Ileal anastomosis(n=60)
19(22.1%)
41(26.3%)
Ileal-colonic
anastomosis(n=4)
2(2.3%)
2（1.3%）
Colonic anastomosis(n=6)
2(2.3%)
4(2.6%)
Surgical
approach
laparoscope（n=54）
19(22.1%)
35(22.4%)
0.951
laparotomy(n=188)
67(77.9%)
121(77.6%)
gender
male(n=130)
44(51.2%)
86(55.1%)
0.554
female(n=112)
42(48.8%)
70(44.9%)
Operative age（d,Median[P25%,P75%]）
39.00[11.00,64.
25]
41.50[8.25,59.00
]
0.810
Operateive weight
（kg,Median[P25%,P75%]）
4.33[3.38,5.03]
4.10[3.05,4.90]
0.571
Pre-operative
37.10[34.50,40.
37.20[33.93,40.0
0.725

albumin(g/L,Median[P25%,P75%]）
15]
0]
Pre-operative
prealbumin(g/L,Median[P25%,P75%]）
0.15[0.11,0.17]
0.14[0.10,0.17]
0.515
Recovery of young infants with intestinal anastomosis after EOF or TOF
gruop
EOF(n=86)
TOF(n=156)
p
weight(kg,Median[P25%,P75%])
4.45[3.40,5.00]
4.10[3.34,5.00]
0.507
albumin(g/L,Median[P25%,P75%])
36.73[34.00,41.50]
37.15[34.23,41.48]
0.510
prealbumin(g/LMedian[P25%,P75%]
)
0.15[0.11,0.19]
0.14[0.11,0.18]
0.255
Time of
TPN(d,Median[P25%,P75%])
2.00[1.00,2.00]
5.00[3.00,6.00]
<0.001
Time of PN(d,Median[P25%,P75%])
7.00[5.00,8.00]
9.00[7.00,13.00]
<0.001
Hospital
stay(d,Median[P25%,P75%])
11.00[8.00,14.00]
14.00[11.00,17.00]
<0.001
complications of young infants with intestinal anastomosis after EOF or TOF
gruop
EOF
（n=86,%）
TOF(n=156,%)
p
Clavien-Dindo
classifification
Grade I (n,%)
11(12.8%)
14(9.0%)
0.351
Grade II(n,%)
6(7.0%)
0(0%)
0.002
Grade III(n,%)
0
1(0.6%)
0.457
Grade IV/V(n,%)
0
0
-
overall
17（19.8%）
15（9.6%）
0.026
Abdominal distension
12(14.0%)
12(7.7%)
0.119
vomit
7(8.1%)
1(0.6%)
0.002
diarrhea
1(1.2%)
2(1.3%)
0.936
hematochezia
1(1.2%)
0(0%)
0.177
anastomotic leakage
0(0%)
1(0.6%)
0.457
Study design: