DOI: 10.1542/peds.

2010-2483
; originally published online September 26, 2011; 2011;128;e771 Pediatrics
Colin V. E. Powell, Stephen J. Priestley, Simon Young and Ralf G. Heine
With Acute Gastroenteritis
Randomized Clinical Trial of Rapid Versus 24-Hour Rehydration for Children

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Randomized Clinical Trial of Rapid Versus 24-Hour
Rehydration for Children With Acute Gastroenteritis
WHATS KNOWN ON THIS SUBJECT: Acute gastroenteritis is a
common cause of dehydration among young children. Oral or
nasogastric rehydration over 4 hours is considered the
treatment of choice in cases of mild-to-moderate dehydration.
Few data on different rehydration schedules are available.
WHAT THIS STUDY ADDS: The study found no differences
between rehydration over 4 vs 24 hours in terms of efcacy and
safety. Although rapid nasogastric rehydration in the emergency
department generally reduced the need for hospitalization,
discharge from the hospital failed for approximately one-fourth
of the patients.
abstract
OBJECTIVE: To compare the efcacy of 2 nasogastric rehydration reg-
imens for children with acute viral gastroenteritis.
METHODS: Children 6 to 72 months of age with acute viral gastroen-
teritis and moderate dehydration were recruited from emergency de-
partments (EDs) at 2 metropolitan, pediatric, teaching hospitals. After
clinical assessment of the degree of dehydration, patients were as-
signed randomly to receive either standard nasogastric rehydration
(SNR) over 24 hours in the hospital ward or rapid nasogastric rehydra-
tion (RNR) over 4 hours in the ED. Primary (2%weight loss, compared
with the admission weight) and secondary treatment failures were
assessed.
RESULTS: Of 9331 children with acute gastroenteritis who were
screened, 254 children were assigned randomly to receive either RNR
(n 132 [52.0%]) or SNR (n 122 [48.0%]). Baseline characteristics
for the 2 groups were similar. All patients made a full recovery without
severe adverse events. The primary failure rates were similar for RNR
(11.8%[95%condence interval [CI]: 6.0%17.6%]) and SNR (9.2%[95%
CI: 3.7%14.7%]; P .52). Secondary treatment failure was more com-
mon in the SNR group (44% [95% CI: 34.6%53.4%]) than in the RNR
group (30.3% [95% CI: 22.5%38.8%]; P .03). Discharge from the ED
after RNR failed for 27 patients (22.7%), and another 9 (7.6%) were
readmitted to the hospital within 24 hours.
CONCLUSIONS: Primary treatment failure and clinical outcomes were
similar for RNR and SNR. Although RNR generally reduced the need for
hospitalization, discharge home from the ED failed for approximately
one-fourth of the patients. Pediatrics 2011;128:e771e778
AUTHORS: Colin V. E. Powell, MD, FRACP, FRCPCH,
a,b,c
Stephen J. Priestley, FACEM,
b,d
Simon Young, FACEM,
a,e,f
and Ralf G. Heine, MD, FRACP
e,f,g
Departments of
a
Emergency Medicine and
g
Gastroenterology
and Clinical Nutrition, Royal Childrens Hospital, Melbourne,
Australia;
b
Department of Emergency Medicine, Sunshine
Hospital, Melbourne, Australia;
c
Department of Pediatrics,
School of Medicine, University of Cardiff, Cardiff, United
Kingdom;
d
Department of Emergency Medicine, Nambour
Hospital, Queensland, Australia;
e
Department of Paediatrics,
Faculty of Medicine, Dentistry, and Health Sciences, University of
Melbourne, Melbourne, Australia; and
f
Murdoch Childrens
Research Institute, Melbourne, Australia
KEY WORDS
dehydration, uid resuscitation, gastroenteritis, nasogastric,
oral rehydration therapy
ABBREVIATIONS
CIcondence interval
EDemergency department
HITHHospital-in-the-Home
ORSoral rehydration solution
ORToral rehydration therapy
RNRrapid nasogastric rehydration
SNRstandard nasogastric rehydration
This trial has been registered at www.anzctr.org.au (identier
ACTRN12610000737033).
www.pediatrics.org/cgi/doi/10.1542/peds.2010-2483
doi:10.1542/peds.2010-2483
Accepted for publication Jun 8, 2011
Address correspondence to Ralf G. Heine, MD, FRACP,
Department of Gastroenterology and Clinical Nutrition, Royal
Childrens Hospital Melbourne, Parkville, Victoria 3052, Australia.
E-mail: ralf.heine@rch.org.au
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright 2011 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no nancial relationships relevant to this article to disclose.
ARTICLES
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The discovery of an oral rehydration
solution (ORS) in 1968 was a major
breakthrough in the treatment of
acute gastroenteritis.
1
Oral rehydra-
tion therapy (ORT) has been hailed as
one of the most signicant medical dis-
coveries,
2
because it has dramatically
reduced the global mortality rates for
young children with acute dehydra-
tion.
3
ORT facilitates increased active
and passive intestinal water absorp-
tion via sodium-glucose transporter 1.
4
Compared with intravenous rehydra-
tion, ORT is associated with a reduced
risk of complications, such as electro-
lyte imbalances, cerebral edema, or
phlebitis.
5
Therefore, ORT is recom-
mended as the treatment of choice for
children with acute gastroenteritis
and moderate dehydration.
69
Since
the introduction of a rotavirus vaccine,
rates of hospitalization for treatment
of acute gastroenteritis have de-
creased in many developed coun-
tries.
1012
In those countries, the rates
of death resulting from acute dehydra-
tion are generally low.
12
However, de-
hydration secondary to viral gastroen-
teritis remains a major cause of
morbidity and death throughout the
world.
3
The American Academy of Pediatrics
recommends rapid nasogastric rehy-
dration (RNR) over 4 hours for the
treatment of children with viral gastro-
enteritis and moderate dehydration.
13
The treatment regimen at the Royal
Childrens Hospital in Melbourne, Aus-
tralia, before the study involved admis-
sion to the hospital and rehydration
over 24 hours, with replacement of the
estimated uid decit over 6 hours
and administration of the 24-hour
maintenance uid requirement in the
subsequent 18 hours (ie, standard na-
sogastric rehydration [SNR]). RNR of-
fers several benets, including a
shorter stay in the hospital and less
disruption of the family routine. The
clinical efcacy of the 2 regimens has
never been formally compared. There-
fore, we aimed to compare the safety
and efcacy of the 2 nasogastric rehy-
dration regimens for children with
acute gastroenteritis. We hypothesized
that RNR would be no worse than SNR
(noninferiority) in treating children
with acute gastroenteritis and moder-
ate dehydration.
METHODS
Screening, Recruitment, and Study
Progress
The study was conducted as a prospec-
tive, randomized, clinical trial in 2 met-
ropolitan, pediatric, teaching hospitals
in Melbourne, Australia. The Royal Chil-
drens Hospital Research and Ethics
Committee approved the study, and
written informed consent was ob-
tained from parents.
During the study period of 18 months,
all children with acute gastroenteritis
who presented to the emergency de-
partment (ED) were screened. Acute vi-
ral gastroenteritis was dened as a
sudden onset of nonbloody diarrhea
(2 loose stools per 24-hour period)
for 7 days, with or without vomit-
ing.
14
Inclusion criteria for participa-
tion in the study were moderate dehy-
dration (dened as a dehydration
score of 36),
15
age between 6 and 72
months, diarrhea for 7 days, resi-
dence in an area covered by the
Hospital-in-the-Home (HITH) service
(determined on the basis of postal
codes), and written informed parental
consent. Exclusion criteria were blood
in stools, an absence of diarrhea (vom-
iting only), signicant other morbidity,
or a dehydration score of 2 or 7.
15
Conduct of the Study
At the time of patient presentation to
the triage nurse in the ED, an indepen-
dent research team (made up of
nurses, emergency fellows, registrars,
and senior emergency staff members)
was informed of the childs arrival (Fig
1). A study information sheet was given
to the parents by the triage nurse. The
clinical admitting team examined the
child and assessed the degree of dehy-
dration, by using the dehydration scor-
ing system described by Gorelick et
al.
15
The research team obtained in-
formed consent from the parents and
collected initial demographic and
physiologic data (childs bare weight
at admission, heart and respiratory
rates, and tympanic temperature). If
the child fullled the inclusion criteria
and the parents consented, then the
child was assigned randomly to re-
ceive either RNR or SNR.
Oral Rehydration Regimens and
Follow-up Monitoring
Patients received an unavored ORS
containing 60 mmol/L sodium, 20
mmol/L potassium, 40 mmol/L chlo-
ride, 10 mmol/L citrate, and 111
mmol/L glucose (Gastrolyte [Aventis
Pharma, Lane Cove, Australia]). Anti-
emetic or antidiarrheal medications
were not used. SNR involved admission
to the hospital ward, where the esti-
mated uid decit (5%7% of body
weight) was replaced with ORS over 6
hours, at a constant rate, through a
nasogastric tube. Patients were reas-
sessed for signs of dehydration after 6
hours. The 24-hour maintenance uid
requirement then was administered
over the subsequent 18 hours. If nec-
essary, clinicians adjusted the rate of
rehydration to reect the volume of on-
going gastrointestinal losses. Clini-
cians were not blinded to treatment
allocation.
RNR consisted of 100 mL/kg ORS, which
was administered over 4 hours (25
mL/kg per hour) in the ED. The patient
then was discharged from the hospital
and was reassessed by a nurse on the
following day, either in a home visit or
with a telephone call after 24 hours. At
the HITH nurse visit, children were
weighed and evaluated with regard to
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overall clinical status (signs of dehy-
dration), as well as assessment of uid
intake and losses.
Both treatment groups were given par-
ent information sheets about gastro-
enteritis. Children admitted to the
ward for the SNR regimen were given
standard nursing and clinical care, as
managed by the inpatient medical and
nursing teams. The research teamwas
not involved in clinical decisions about
readmission, alterations of the uid
regimen once the initial rehydration
was completed, or clinical decisions to
change to intravenous rehydration.
Assessment of Severity of
Gastroenteritis and Degree of
Dehydration
The scoring system described by
Flores et al
16
was used to grade the
severity of viral gastroenteritis.
Scores are based on symptoms of viral
gastroenteritis, including the duration
of diarrhea (in days), the maximal
number of diarrheal stools per 24
hours, the duration of vomiting (in
days), a rectal temperature of
38.1C, the presence of dehydration
of 5%, and the need for hospital ad-
mission (score range: 214). The se-
verity of dehydration was graded ac-
cording the scoring system described
by Gorelick et al.
15
Scores are based on
10 clinical signs of dehydration
(sunken fontanel, tachycardia, in-
creased capillary rell time, weak
pulse, abnormal respirations, dry mu-
cous membranes, oliguria, decreased
skin turgor, absent tears, and poor
general appearance); items are rated
as present or absent (score range:
010). For purposes of the study, mod-
erate dehydration was dened as
scores between 3 and 6. Children with
minor dehydration (scores of 02) or
severe dehydration (scores of 710)
were not enrolled.
Measurement of Body Weight and
Physiologic Data
The study used 4 sets of scales that
were used exclusively for the study.
Each set of scales was calibrated daily.
Each child was weighed on 4 occa-
sions, that is, at recruitment (baseline
weight), after 4 hours for RNR or 6
hours for SNR, at 24 hours, and at 7
days after admission (well weight).
Physiologic and clinical data were as-
sessed by the clinical team at presen-
tation. Bare weight, dehydration
score,
15
and physiologic data were re-
corded by the research team at re-
cruitment, at 4 hours for RNR and 6
hours for SNR, at 24 hours after re-
cruitment, and at 1 week after
presentation.
Study Outcomes
Study outcomes were assessed by a
research team member who was not
blinded to treatment allocation. Pri-
mary treatment failure was dened as
an additional loss of 2% at any time
during the rehydration process, com-
pared with the admission weight.
14
Secondary treatment failure was de-
ned as an inability to tolerate the in-
sertion of a nasogastric tube, frequent
or persistent vomiting, commence-
ment of intravenous rehydration, con-
tinued signs of moderate dehydration
(3 clinical signs), a need for naso-
gastric uids beyond 24 hours
(SNR only), or impending circulatory
collapse.
14
Sample-Size Calculation
The sample-size calculation was based
on the assumption that RNR would be
no worse than SNR in the treatment of
moderate dehydration (noninferiority
Study period
Screening of patients in ED
Information handout

t = a Clinical assessment
Clinical history and examination
Dehydration score (assessed by clinicians)
Diarrhea severity score

t = 0 Consent and randomization
Dehydration score and weight (assessed by research team)
Diarrhea severity score

t = 1 Nasogastric rehydration regimen
Rapid rehydration in ED Slow rehydration in hospital ward
ORS 100 mL/kg body weight Replacement of estimated fluid deficit
over 4 h (via NG tube) with ORS over 6 h (via NG tube)
Dehydration score and weight
Clinical assessment
Discharge home with instructions Patient remains in hospital ward
e b u t G N a i v h 8 1 r o f S R O
Continued oral rehydration at home (24-h maintenance volume
) h 8 1 r e v o d e r e t s i n i m d a

t = 2 24-h follow-up
Home visit by nursing team Assessment before hospital discharge
Dehydration score and weight

t = 3 7-d follow-up at home
Dehydration score
Weight (well weight)
Discharge from study
FIGURE 1
Study design. NG indicates nasogastric.
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trial). A previous rehydration trial de-
ned treatment failure as weight loss
of 2%.
14
In that study, treatment fail-
ure occurred for 3.8% of patients (up-
per 95% condence limit: 11.6%). For
the purposes of our sample-size calcu-
lation, we assumed primary failure
rates of 4% in both treatment arms.
With the use of the Newcombe-Wilson
method,
17
250 children in each treat-
ment arm would be required to dem-
onstrate that the 2-sided condence
interval (CI) for the difference in pri-
mary failure rates would not extend
6% in each direction (power: 80%;
.05).
Randomization
The randomization and organization of
the process were supervised by 1
member of the research team (Dr
Heine), who was not directly involved
in the clinical care of patients in the ED.
A randomization list was generated by
computer, by using blocks of 6. The
treatment group allocation details
were stored safely in the ED, in sequen-
tially numbered, opaque, sealed enve-
lopes. Group allocation remained con-
cealed until written parental consent
was obtained.
Data Analyses
Data were recorded on a clinical re-
cord form and were treated with strict
condentiality. Per-protocol analysis
of clinical outcomes was performed by
using SPSS (SPSS Inc, Chicago, IL).
Analyses used the
2
test or Fishers
exact test for categorical data; Stu-
dents t test was used for continuous
data and the Mann-Whitney U test for
nonparametric data. Data were pre-
sented as means or proportions with
95% CIs.
RESULTS
Study Groups
Of 9331 patients with gastroenteritis
who were screened, 7988 (85.6%) had
only mild dehydration and were
treated with oral rehydration at home.
Figure 2 summarizes the recruitment
process. We identied 377 eligible pa-
tients with moderate dehydration, of
whom254 (67.4%) were enrolled in the
study; 132 (52.0%) were assigned ran-
domly to receive RNR and 122 (48.0%)
SNR. A total of 26 patients were ex-
cluded after randomization because of
protocol violations or noncommence-
ment of randomized treatment. The -
nal per-protocol analysis was based
on the remaining 228 patients (RNR:
119 patients; SNR: 109 patients).
Recruitment did not yield the number
of patients estimated in the sample-
size calculation. The main reason for
underrecruitment was the fact that
the number of patients with moderate
dehydration who presented to the ED
was signicantly lower than antici-
pated, because the vast majority of pa-
tients screened had only mild dehydra-
tion. Reasons for nonenrollment of
eligible patients included failure to ob-
tain parental consent and presenta-
tion to the ED late at night or on week-
ends, when the research team was not
available.
The mean SE age of the recruited
cohort (N 228) was 25 0.1 months
(range: 671 months). There were 124
male patients (54.4%). Table 1 summa-
rizes the baseline characteristics of
the treatment groups. There were no
signicant group differences with
regard to age, gender, severity of
diarrhea, degree of dehydration, ad-
mission weight, or physiologic
parameters.
Primary Outcomes
All patients in the study made a full
recovery from gastroenteritis, and
there were no serious adverse events
or episodes of circulatory collapse.
With use of the denition of primary
treatment failure described by Mack-
enzie and Barnes,
14
14 children (11.8%
[95% CI: 6.0%17.6%]) in the RNR
group and 10 children (9.2% [95% CI:
3.7%14.7%]) in the SNR group experi-
enced 2% weight loss during the
study period (
2
0.405; P .52).
Overall, this represents a difference in
Patients with acute gastroenteritis Mild dehydration only
n = 9331 n = 7988
Refused consent Admitted to hospital Exclusion criteria
n = 50 n = 1343 n = 966
Fulfilled inclusion criteria Missed recruitment
n = 327 n = 73
Total enrolled
n = 254
Randomized Randomized
to RNR to SNR
Excluded from analysis n = 132 n = 122 Excluded from analysis
Missing data; n = 5 Missing data; n = 6
Protocol violation; n = 3 Protocol violation; n = 2
Other illness; n = 4 Continued Continued Other illness; n = 5
Withdrew consent; n = 1 RNR SNR
n = 119 n = 109
Loss to follow-up Loss to follow-up
n = 6 n = 15
Completed Completed
RNR SNR
n = 113 n = 94
FIGURE 2
Recruitment and study progress.
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primary treatment failure rates be-
tween groups of 2.6% (95% CI: 5.3%
to 10.5%). There were no signicant
differences in primary outcome mea-
sures at any time point during the
study (Table 2).
Secondary Outcomes
On the basis of the criteria for second-
ary treatment failure at 4 to 6 hours,
there were no signicant differences
between the 2 rehydration regimens
(27 of 119 vs 29 of 109 children;
2

0.471; P .49). At 24 hours and 7 days

after admission, however, secondary
treatment failure was more common
in the SNR group (RNR: 36 [30.3%] of
119 children; SNR: 48 [44.0%] of 109
children;
2
4.64; P .03) (Table 3).
Insertion of an intravenous cannula
was required for 7 (5.9% [95% CI:
2.9%11.7%]) of 119 patients receiving
RNR and 5 (4.9% [95% CI: 2.0%10.3%])
of 109 patients receiving SNR (
2

0.191; P .66). Persistent vomiting

was the most common reason (6
[50.0%] of 12 patients) for treatment
with intravenous uids, although only
9 patients (3.9%) in the study experi-
enced failure of nasogastric rehydra-
tion because of vomiting. There were
no group differences in the rates of
persistent vomiting as a cause of sec-
ondary treatment failure (RNR: 6 of 119
patients; SNR: 3 of 109 patients; P
.38). The times spent in health care
from admission to discharge were
similar for the 2 groups (RNR including
HITH: 35.5 hours [95% CI: 29.241.8];
SNR: 37.4 hours [95% CI: 33.940.9]).
Of the 119 children who were assigned
randomly to receive RNR, 36 children
(30.3%) required admission to the hos-
pital. After the initial rehydration
phase, 27 patients (22.7%) failed to be
discharged from the hospital from the
ED. At the 4-hour assessments after
RNR, 14 patients (11.8%) were deemed
to be moderately dehydrated, with 3
clinical signs. Of those patients, 7 had
weight loss of 2% (primary treat-
ment failure). Nine patients (7.6%)
were readmitted to the hospital at 24
hours because of clinical signs of de-
hydration (n 8) or persistent vomit-
ing (n 1). The patient with persistent
vomiting was treated with intravenous
uids, and all other patients who were
readmitted at 24 hours were treated
successfully with SNR. Apart from on-
going dehydration, reasons for sec-
ondary treatment failure of RNR at 4
hours and 24 hours included persis-
tent vomiting (n 6), parental con-
cern and requests for SNR (n 3) or
intravenous rehydration (n 1), and
TABLE 1 Baseline Characteristics of Subjects Assigned Randomly to Receive RNR or SNR
RNR (N 119) SNR (N 109)
Age, mean SE (95% CI), mo 24.5 1.29 (21.929.0) 25.8 1.5 (22.828.8)
Flores score at assessment, mean SE (95% CI)
16,a
9.3 0.21 (8.99.7) 9.8 0.2 (9.410.2)
Dehydration score at assessment, mean SE
(95% CI)
15,a
4.7 0.12 (4.45.0) 4.9 0.13 (4.65.1)
Dehydration score at randomization, mean SE
(95% CI)
15,b
4.9 0.12 (4.75.1) 4.9 0.12 (4.75.1)
Admission weight, mean SE (95% CI), kg 12.2 0.29 (11.712.8) 11.9 0.29 (11.312.5)
Temperature, mean SE (95% CI), C 37.3 0.09 (37.137.5) 37.5 0.12 (37.337.7)
Heart rate, mean SE (95% CI), beats per min 136 2.19 (132140) 133 2.30 (128138)
Respiratory rate, mean SE (95% CI), breaths per min 30 0.70 (2832) 32 0.87 (3034)
a
Time of rst clinical assessment.
b
Time of consent and randomization.
TABLE 2 Comparison of Primary Treatment Failure Rates After 4 to 6 Hours, 24 Hours, and 7 Days
Primary Treatment Failure, n/N (% [95% CI]) P
RNR SNR
First period of rehydration (0 to 46 h) 1/119 (0.8 [02.4]) 2/109 (1.8 [04.3]) .516
Second period of rehydration (46 to 24 h) 12/118 (10.2 [4.715.7]) 5/107 (4.7 [0.78.7]) .119
7-d follow-up period (24 h to 7 d) 1/106 (0.9 [02.6]) 3/102 (2.9 [06.2]) .294
Primary treatment failure at any time
point (0 h to 7 d)
14/119 (11.8 [617.6]) 10/109 (9.2 [3.714.7]) .524
Treatment failure was dened as a 2.0% decrease in weight at any time during the study, compared with the admission
weight.
TABLE 3 Comparison of Secondary Treatment Outcomes at 4 to 6 Hours, 24 Hours, and 7 Days
Reason for Secondary Treatment Failure RNR (N 119) SNR (N 109) P
4 h, n 24 h, n 7 d, n Total, n (% [95% CI]) 6 h, n 24 h, n 7 d, n Total, n (% [95% CI])
3 clinical signs of dehydration 14 (1)
a
8 0 22 (18.4 [11.425.4]) 25 (2)
a
5 1 31 (28.4 [19.637.2]) .08
Persistent vomiting 5 (3)
a
1 (1)
a
0 6 (5.0 [1.09.0]) 1 (1)
a
2 (1)
a
0 3 (2.8 [05.9]) .38
Parental concern 4 (1)
a
0 0 4 (3.3 [0.16.5]) 1 (1)
a
1 0 2 (1.8 [04.4]) .47
Not tolerating nasogastric tube 1 (1)
a
0 0 1 (0.8 [02.4]) 2 0 0 2 (1.8 [04.4]) .51
Change to SNR at 4 h because of high-
volume uid losses
b
3 0 0 3 (2.5 [05.3]) NA NA NA NA
Need for nasogastric uids beyond 24 h
b
NA NA NA NA 0 10 0 10 (9.2 [3.714.7])
Total 27 (6)
a
9 (1)
a
0 36 (30.3 [22.538.8]) 29 (4)
a
18 (1)
a
1 48 (44.0 [34.653.4]) .03
NA indicates not applicable.
a
Numbers in parentheses indicate the numbers of children treated with intravenous rehydration.
b
On the basis of clinical decisions by the treating medical team.
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failure to tolerate the nasogastric tube
(n 1). Three patients (2.5%) were
switched to SNR by the treating medi-
cal team because of signicant ongo-
ing uid losses. There were no late re-
admissions after 24 hours after the
initial admission to the ED.
Of the 109 patients who were assigned
randomly to receive SNR, 29 (26.6%)
were classied as experiencing sec-
ondary treatment failure at 6 hours.
Reasons for treatment failure included
ongoing moderate dehydration (n
25), for which 2 patients required in-
travenous rehydration. Persistent
vomiting led to secondary treatment
failure for 3 patients (2.8%). Four pa-
tients (3.7%) in the SNR group re-
quired intravenous uids within 6
hours after hospital admission. Ten
patients (9.2%) were assessed to have
signicant ongoing uid losses or in-
adequate oral uid intake at 24 hours
and continued to receive nasogastric
uids beyond 24 hours.
Weight Gain and Signs of
Dehydration
Table 4 summarizes the changes in de-
hydration scores throughout the
course of the study. In the SNR group,
there was a trend toward higher dehy-
dration scores at 6 hours after admis-
sion. Dehydration scores at 24 hours
and 7 days were similar for the 2 rehy-
dration regimens. In Table 5, the per-
centage changes in body weight over
time are shown. At 4 to 6 hours, after
the initial rehydration phase, weight
gain was signicantly greater for the
RNR group (P .001). At 24 hours, both
groups had lost weight but the SNR
group had maintained signicantly
better hydration, compared with the
RNR group (P .001). At the nal
follow-up assessment after 1 week,
weight gains were similar for the 2
groups.
DISCUSSION
The present randomized clinical trial
compared 2 nasogastric rehydration
regimens for children 6 months to 6
years of age with acute viral gastroen-
teritis and moderate dehydration. Our
study found no differences between
the 2 rehydration regimens in terms of
the efcacy and safety outcomes ex-
amined. All 228 children in the study
were treated successfully and made a
full recovery, regardless of treatment
allocation. There were no serious ad-
verse events. Primary treatment fail-
ure, dened as weight loss of 2% be-
tween presentation and any time point
during the study, occurred at similar
rates for children undergoing rehydra-
tion over 4 hours in the ED and those
undergoing rehydration over 24 hours
in the hospital. The difference in pri-
mary treatment failure rates was 2.6%
in favor of SNR. Because of the incom-
plete recruitment, however, the CIs
were too wide for reliable assessment.
Therefore, the study failed to demon-
strate noninferiority of RNR against
SNR. The secondary failure rate was
signicantly higher for SNR, in part be-
cause of treatment decisions by medi-
cal staff members to continue naso-
gastric rehydration beyond 24 hours in
the hospital.
Oral or nasogastric rehydration is
highly effective for treatment of pa-
tients with moderate gastroenteritis. A
meta-analysis by Gavin et al
18
dened
failure of ORT as the need to revert to
intravenous therapy and reported an
overall failure rate of 3.6% (95% CI:
1.4%5.8%). Our study found slightly
higher intravenous cannulation rates
of 5.9% for RNR and 4.9% for SNR; how-
ever, these rates were still closely
aligned with the CIs from the meta-
analysis.
18
Although persistent vomit-
ing generally did not preclude naso-
gastric rehydration, it was the reason
for one-half of the unscheduled intra-
venous cannula insertions (6 of 12 in-
sertions) in the trial. An additional 3
patients who remained clinically dehy-
drated after the initial rehydration
phase at 4 to 6 hours also were treated
with intravenous uids (SNR: 2 pa-
tients; RNR: 1 patient). The remaining 3
intravenous cannula insertions in the
trial were attributable to failure to tol-
erate the nasogastric tube (1 patient)
and parental concern and requests for
intravenous rehydration (2 patients).
The decision to change to intravenous
uid resuscitation in the present trial
was left to the treating clinical team
and might have been prone to bias, be-
cause the treatment allocation was not
concealed.
Assessment of the degree of dehydra-
tion relied on a validated clinical scor-
ing system
15
and serial body weight
measurements. Body weight was the
basis of the primary treatment out-
come, and great care was taken to ob-
tain consistent accurate measure-
ments. Patients were weighed on the
same set of calibrated scales, to re-
duce inaccuracies between scales. In
addition, the research team was not
directly involved in clinical care, which
reduced performance bias. Clinicians
TABLE 4 Comparison of Dehydration Scores
at Baseline and 4 to 6 Hours, 24
Hours, and 7 Days After
Commencement of Rehydration
Time Dehydration Score,
Mean (95% CI)
P
RNR SNR
Baseline 4.89 (4.665.13) 4.90 (4.675.14) .97
46 h 1.49 (1.211.76) 2.04 (1.742.34) .09
24 h 1.35 (1.101.63) 1.59 (1.291.89) .26
7 d 0.10 (0.090.11) 0.10 (0.090.11) .46
TABLE 5 Comparison of Percentage Changes
in Body Weight From Baseline to 4 to
6 Hours, 24 Hours, and 7 Days After
Commencement of Rehydration
Time Weight Gain,
Mean (95% CI), %
P
RNR SNR
46 h 4.4 (4.04.9) 3.3 (2.83.8) .001
24 h 0.9 (0.41.4) 2.4 (1.82.9) .001
7 d 3.0 (2.33.6) 2.7 (3.04.3) .66
e776 POWELL et al
at Indonesia:AAP Sponsored on April 15, 2014 pediatrics.aappublications.org Downloaded from
assessing patients for dehydration
and making decisions about readmis-
sion to the hospital were not blinded to
treatment allocation. The tendency of
clinicians to overestimate dehydration
is well recognized.
14,15
Table 4 indicates
that the well weights at the 7-day re-
view were 3% to 4% higher than the
admission weights, which is less than
the 5% to 10% generally predicted for
moderate rehydration.
14
This differ-
ence is of similar magnitude as those
found in other studies
14,15
and may be
explained, in part, by a loss of lean
body mass as a result of reduced en-
ergy and protein intakes, increased in-
testinal losses, and increased nutri-
tional requirements for mucosal
regeneration during the illness. In ad-
dition, the real loss in body weight with
moderate dehydration may be smaller
than generally assumed.
The present study had several limita-
tions. Apart from the rehydration
schedules, clinical decisions were not
protocol-based and were left to the
treating medical team. Because of the
nature of the treatments, blinding of
the interventions was not possible.
This might have introduced some bias
from the treating medical teams or
parents favoring a particular interven-
tion. Although the 2 groups received
similar information sheets and med-
ical advice from ED staff members,
parents and medical staff members
might have perceived RNR as being
less efcacious than 24-hour rehy-
dration in the hospital (SNR was the
established clinical practice at the
time). Conversely, hospital staff
members might have prolonged na-
sogastric rehydration in the hospital
for patients with signicant ongoing
uid losses, because HITH follow-up
care was not an established clinical
pathway. In our study, 10% of pa-
tients treated with SNR received na-
sogastric uids beyond 24 hours.
Because our study did not reach the
targeted sample size, the noninferior-
ity comparison between RNR and SNR
remained inconclusive. However, the
study still provides useful clinical in-
formation about the 2 rehydration reg-
imens. RNR was successful for 70% of
patients, whereas 30% either were not
discharged from the ED or were read-
mitted to the hospital within 24 hours.
Only 5.9% of RNR-treated patients re-
quired intravenous uid resuscitation.
Therefore, RNR in the ED provides a
useful alternative to 24-hour nasogas-
tric rehydration in the inpatient set-
ting. The reduced need for hospitaliza-
tion is likely to be associated with
signicant clinical and economic ben-
ets, including reduced risk of nosoco-
mial cross-infection. The cost of pri-
mary care or HITH follow-up care,
which was an integral part of the RNR
intervention, needs to be considered
as part of the economic evaluation.
However, a detailed economic analysis
of either rehydration regimen was be-
yond the scope of the present study.
CONCLUSIONS
RNR should be considered as an al-
ternative to SNR for children (6 72
months of age) with moderate dehy-
dration attributable to viral gastro-
enteritis. Close follow-up monitoring
after discharge from the ED is man-
datory, to detect ongoing gastroin-
testinal losses or worsening dehy-
dration. For patients who were
readmitted after 24 hours of RNR, a
second period of nasogastric rehy-
dration usually was effective; intra-
venous rehydration was required for
only a small number of patients. An-
tiemetic agents, such as ondanse-
tron, have been used in the ED to
improve the efcacy of oral or naso-
gastric rehydration.
19
Additional clin-
ical studies to assess the role of an-
tiemetic medications as an adjunct
to RNR for young children are
encouraged.
ACKNOWLEDGMENTS
This study was supported by a clinical
research grant from the Department
of Human Services, Government of Vic-
toria (Melbourne, Australia).
We thank Carly Hyett and Anne Wil-
liams, research nurses, who were in-
volved with the conduct of the study.
We also thank Prof Ann-Marie Kelly
from the Joseph Epstein Centre for
Emergency Medicine Research, Sun-
shine Hospital (Melbourne, Australia),
for her support and advice. The contri-
butions of all clinical and research
staff members at both hospitals, as
well as the families and children who
participated in the study, are grate-
fully acknowledged.
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DOI: 10.1542/peds.2010-2483
; originally published online September 26, 2011; 2011;128;e771 Pediatrics
Colin V. E. Powell, Stephen J. Priestley, Simon Young and Ralf G. Heine
With Acute Gastroenteritis
Randomized Clinical Trial of Rapid Versus 24-Hour Rehydration for Children

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