PEDIATRICS Vol. 100 No. 5 November 1997,
p. e3
Copyright © by the American Academy of Pediatrics
ELECTRONIC ARTICLE:
Safety and Effectiveness of Homemade and Reconstituted Packet
Cereal-based Oral Rehydration Solutions: A Randomized Clinical Trial
Alan Meyers*,
Amy Sampson*,
Richard Saladino
,
Sujata Dixit§,
William Adams*, and
Alejandro Mondolfi
From the * Division of General Pediatrics, Boston Medical
Center, Boston University School of Medicine, Boston, Massachusetts;
Division of Emergency Medicine, Children's Hospital, Harvard
Medical School, Boston, Massachusetts; and § Department of Maternal and
Child Health, Harvard School of Public Health, Boston, Massachusetts.
ABSTRACT
INTRODUCTION
METHODS
RESULTS
DISCUSSION
FOOTNOTES
ACKNOWLEDGMENTS
ABBREVIATIONS
REFERENCES
ABSTRACT
Objectives. Parents may be deterred from
obtaining commercial oral rehydration solutions (ORS) for their young
children with acute diarrheal disease because of its availability
and/or cost, especially if they are poor. We conducted a randomized
clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these
CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing
severity and duration of illness.
Methods. Children 4 to 36 months of age discharged from
emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet
CBORS, or Pedialyte. A study nurse saw the child at home each day until
the illness resolved, and obtained capillary blood for serum sodium at
enrollment and at 24 to 48 hours; a sample of CBORS for sodium
concentration; stool for pathogen analysis; and daily fluid intake,
stool frequency, and weight.
Results. A total of 232 children were enrolled, of whom
203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors
resulting in a high sodium concentration (>100 mEq/L); their children
refused the solution and had normal serum sodium values. Mean CBORS
sodium concentration for the remainder of the homemade CBORS group was
60 ± 10 mEq/L, and for the packet CBORS group, 54 ± 13. Eighteen children (11%) had abnormal serum sodium values at
presentation, which returned to normal in all groups in most cases.
Three children (4.5%) in the homemade CBORS group, 4 (6%) in the
packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed
therapy.
Children refused to take homemade CBORS and packet CBORS (43% and
32%, respectively) more often than Pedialyte (9%), and those in the
CBORS groups tended to take less ORS and total fluids. There were no
significant differences among the three groups in incidence of daily
vomiting or stooling, duration of diarrhea, or weight gain.
Conclusions. CBORS do not offer a clinically significant
advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest
alternative for regular clinical use.
Key words:
diarrhea,
dehydration,
oral rehydration,
cereal.
INTRODUCTION
Acute infectious diarrhea is a common illness in young
children worldwide and in the United States, where children average between 1.3 and 2.3 episodes per child per year for the first 5 years
of life.1 Each year, approximately 1 of 5 children <5 years of age sees a physician for diarrhea, and 1.4%
are hospitalized, resulting in >200 000 hospital admissions, or
10.6% of all admissions in this age group.1 It has been
estimated that the annual national cost of hospitalization for
rotavirus-associated gastroenteritis was $352 million in
1988.2 Some 300 children <5 years of age die in the United
States each year because of diarrhea, a rate that has not declined
since 1985. These deaths occur primarily in infants and
disproportionately among those who are African-American, premature, and
living in Southern states and in metropolitan areas.3
Oral rehydration therapy (ORT) is safe, effective, less invasive, and
less expensive than intravenous rehydration for the treatment of
diarrheal dehydration, and its use in the home early in the course of
illness can prevent the development of dehydration.4 ORT
has been promoted in practice guidelines published by the American
Academy of Pediatrics (AAP)9,10 and the Centers for Disease
Control and Prevention.11 However, there are economic barriers to the use of ORT for low-income families,12 who
may have to pay >$6 per liter in their neighborhood pharmacy for
commercial oral rehydration solutions (ORS). Coverage of commercial ORS
varies among the state Medicaid programs,13 and one fourth
of children in low-income families in the United States have no health
insurance coverage at all.14
A possible approach to this problem is the promotion by health
professionals of ORS prepared from ingredients commonly found in the
home, as is done in some programs in poor countries.15 However, there are concerns that inaccurate measurement of either sugar
or salt could produce an ineffective or dangerous
mixture,16 and the safety and effectiveness of homemade ORS
in the United States has not been reported. Cereal-based oral
rehydration solutions (CBORS) may be prepared from ingredients found in
most households, and homemade CBORS should be safer than homemade
sugar-salt solutions because of its lower osmolality if prepared with
an inappropriately small volume of water.17 CBORS using
rice or other cereals at concentrations of 50 to 80 g/L have been shown
to be as effective as glucose-based solutions in restoring and
maintaining hydration; in some studies, its use has reduced stool
output, shortened the course of diarrheal illness, reduced vomiting,
decreased the volume of oral solution needed, and improved weight
gain.18,19
To assess the safety and effectiveness of homemade CBORS and CBORS
prepared from a packet of premeasured dry ingredients, we conducted a
randomized clinical trial. The hypotheses tested were 1) when
adequately instructed, parents from a variety of ethnic and educational
backgrounds are able to safely prepare and administer CBORS made from
ingredients commonly found in the home or reconstituted from a packet
of premixed ingredients; 2) CBORS prepared and administered at home are
as effective as commercially available glucose-based ORS in maintaining
hydration in children with acute diarrheal disease; and 3) CBORS used
in the maintenance phase of ORT are more effective than glucose-based
ORS in decreasing the incidence of vomiting, number of stools per day,
volume of ORS consumed, and duration of diarrhea, and in increasing
weight gain.
METHODS
Children presenting to the pediatric emergency departments or
primary care clinics of Boston City Hospital and Boston Children's Hospital or any of seven Boston neighborhood health centers were considered eligible for study if they met the following criteria: 1)
age between 4 and 36 months; (2) discharged from treating site with the
diagnosis of acute diarrheal disease (defined as the passage of at
least one diarrheal stool in the 24 hours before registration) with
normal hydration status (in the judgment of the attending physician) by
the end of the visit; (3) had had rice introduced to the diet; (4) had
a legal guardian available who was fluent in English, Spanish, French,
or Haitian Creole, able to follow written instructions, available for
home visits, and living within the geographic range of the study; and
(5) the attending physician agreed that the child may be included in
the study. Children were considered ineligible for study if they 1) presented with diarrhea of >7 days' duration; 2) had received antibiotics during the 7 days before presentation; 3) were known to
have a chronic gastrointestinal or immune disorder; or 4) if the study
nurse judged the parent/guardian to be unable to adhere to the protocol
instructions. Study nurses were on site at the two emergency
departments during peak visit times (usually 2 PM to 10 PM), 7 days per
week. They reviewed presenting complaints of all children in the target
age range and approached the parent/guardian of those patients whose
presenting complaint was consistent with a diagnosis of acute diarrheal
disease (ie, diarrhea, vomiting, fever). Potentially eligible patients
presenting at participating health centers were identified by health
center nursing staff, and a study nurse was contacted to visit the
health center and interview the parent. For study participants, the
study nurse obtained informed consent, administered a structured
questionnaire, and obtained capillary blood for serum sodium assay.
Children were assigned to one of three treatment groups using
randomization in blocks of nine subjects each. Group 1 received homemade CBORS, prepared by mixing 2 cups of water, 1/2 cup of
instant baby rice cereal (Gerber Products Co, Fremont, MI), and
1/4 level measuring teaspoon of table salt. This mixture was
calculated to contain 50 mEq/L sodium, 1 mEq/L potassium, and 60 g/L
cereal. Group 2 received CBORS, prepared by mixing ingredients from a packet (provided by the Gerber Products Company) with 8 oz of water and
containing 60 mEq/L sodium, 15 mEq/L potassium, 48 mEq/L chloride, 25 mEq/L bicarbonate, and 80 g/L cereal. Group 3 received Pedialyte
(Abbott Laboratories, Columbus, OH), a commercially available
glucose-based ORS (45 mEq/L sodium, 20 mEq/L potassium, 35 mEq/L
chloride, 30 mEq/L citrate, and 25 g/L glucose).
The study nurse assessed the ability of parents assigned to the
homemade and packet CBORS groups to correctly identify the household
measures used to prepare the solution. Parents were given all materials
necessary to prepare and administer the study solution, including
measuring utensils and containers for the CBORS groups and Pedialyte
for the control group. Instructional leaflets describing how to prepare
and administer the study solutions were given along with leaflets
describing recommended feeding practice during diarrhea and prevention
of transmission of diarrheal disease. Parents were instructed to give
the child her/his usual volume of liquids plus an additional volume,
which the nurse calculated as 10 mL/kg, for each diarrheal stool. They
were advised to alternate the study solutions with the child's other
regular liquids, but to avoid sweetened beverages such as juice or soda
pop unless diluted with an equal volume of plain water. It was
suggested that liquids be given from a bottle or cup, but that if the
child vomited the liquid, to give 1 teaspoonful every few minutes until the vomiting ceased. To ensure uniformity of dietary advice, parents were also advised to avoid milk and milk formula, but to continue the
child's usual solids. All educational materials were available in
English, Spanish, and French. Parents also received diapers; soy
formula; A & D ointment (Moore Medical, New Britain, CT); stickers,
marker pens, and plastic bags for labeling and collecting soiled
diapers; and a canvas tote bag.
Parents were instructed to save all soiled diapers, mark each diaper
with the time of its changing, and record fluid intake on a daily log
sheet. A study nurse visited the home each day, beginning on the day
after enrollment and continuing until the end of illness, which was
defined as passage of a formed stool followed by at least 48 hours with
no recurrence of diarrhea. At each visit, the study nurse reviewed the
history of liquid intake and stool frequency, performed a clinical
assessment of hydration status, and examined the soiled diapers
collected since the previous visit. On the first home visit, a sample
of CBORS prepared by the parent was collected and assayed for sodium,
and stool was obtained for pathogen analysis, which included culture for Salmonella, Shigella, Yersinia,
Campylobacter, and Escherichia coli O157:H7;
specimens for rotavirus antigen assay were frozen and assayed in
batches (Sanofi Diagnostics Pasteur, Chaska, MN). Within 24 to 48 hours
after enrollment, a second capillary blood specimen was obtained for
serum sodium assay. A mixing failure was defined as CBORS
prepared by the parent with a sodium concentration of >100 mEq/L.
In all such cases, a repeat test for serum sodium level was obtained,
CBORS discontinued, and the parent provided with Pedialyte and followed
until resolution of illness. If the child appeared to be dehydrated or
had other signs of clinical concern, the home visiting nurse referred
the child back to her/his original treatment or primary care site. A
treatment failure was defined as occurrence of dehydration
as assessed by the child's clinician at any time after enrollment or
any child with serum sodium >150 or <130 at 24 to 48 hours.
These children were removed from the study and given standard clinical
care. A study nurse visited families at ~1 week after the end of
illness to obtain an interval history and weight. Outcome measures
included mixing and treatment failures, occurrence of vomiting, daily
frequency and duration of diarrhea, and weight change at end of illness and 1 week later.
Statistical Methods
Proportions were compared using the
2
statistic. Medians were examined when data distributions were skewed
and compared using nonparametric median tests. The SPSS statistical
package was used for statistical analysis.20 Exact
one-sided upper limit of 95% confidence intervals (CI) was calculated
for mixing failure rates and treatment failure rates using the Fisher
exact confidence limits, as described by Sahai and
Khurshid.21 In comparing total liquid intake data among the
three groups, data were edited to remove biologically implausible
outliers (total fluid intake >300 mL/kg/day).
RESULTS
Between November 1, 1994 and April 28, 1996, 505 parents whose
children appeared to meet the study criteria were invited to participate in the study, of whom 177 (35%) declined and 96 (19%) were found to be ineligible on further examination. A total of 232 children were enrolled, of whom 203 (88%) were followed to an endpoint
(end of illness or mixing/treatment failure). Children lost to
follow-up (n = 29) and those followed to an endpoint did not
differ by demographics, illness history, stool pathogens, or treatment
group. Data are presented for the 203 children followed to an endpoint.
Demographics of the children are shown in Table 1: mean age was 15 ± 8 months; 38%
were Latino (a category which included Puerto Rican [18%], Central
American [10%], Dominican [6%], and other Latino [4%]), 30%
were African-American, and 10% were Haitian; 87% of children
participated in the Special Supplemental Food Program for Women,
Infants, and Children. Sixty-five percent of mothers reported ever
breastfeeding. Ninety-seven percent of parents reported the child's
having a primary care clinician, and 56% had not contacted their
doctor before bringing the child for care.
Illness characteristics are shown in Table 2.
Parents reported a mean of 6.6 stools in the 24 hours before
presentation and 2.2 days with diarrhea before presentation, and 72%
reported vomiting. In the judgment of the attending physician, 60% of
children were not dehydrated, whereas 34% had mild, 5% moderate, and
0.5% severe dehydration. Stool samples were available for rotavirus
assay from 175 children (86%), of whom 47 (27%) had a positive
result. A total of 163 specimens (80%) were assayed for bacterial
pathogens, of which 5 (3%) were positive for Salmonella and
3 (2%) for Campylobacter. Demographics, illness
characteristics, etiology, and degree of dehydration did not vary
significantly by treatment group assignment.
When asked whether they had heard of drinks that could be
purchased in a store or pharmacy to treat children with diarrhea and/or
vomiting, 157 parents (77%) responded that they had, with 151 (96%)
naming Pedialyte. A total of 121 parents (60%) reported that they had
given their child Pedialyte in the past, and 70 children (36%) were
being given Pedialyte at the time of enrollment. There was no
difference in history of previous ORS use by treatment group
(P = .31). A total of 67% of parents reported
that they had a measuring cup in the household, 50% had a measuring
spoon set, 97% had salt, 95% had sugar, and 60% had instant baby
rice cereal; 26% had all of the ingredients necessary to prepare
homemade CBORS.
CBORS Sodium Concentration
The distribution of sodium values in the homemade solutions
prepared by study parents is shown in Figure
1. There were two mixing failures in this
group (2/66 = 3.0% [one-sided upper limit of 95% CI = 9.2%]). In the first case, the mother mixed a solution with a sodium
concentration of 255; she reported that she had not read the directions
when preparing the study mixture, nor did she remember which spoon she
had used to measure the salt. When asked by the study nurse to prepare
the solution again, the mother replied that she had given away both the
instructions and measuring materials. In the second case, the father
had received the enrollment instructions, but the mother had prepared
the solution; the mixture sample had a sodium concentration of 191 mEq/L. Both children were reported to have refused the solution, and
both were found to have normal serum sodium values. The mean solution sodium concentration for the remainder of the group was 54 ± 13 mEq/L. Five parents mixed solutions with low sodium concentration (ranging from 10 to 37 mEq/L). In one case, the initial serum sodium
concentration was 148 mEq/L, and follow-up was 140 mEq/L after
administration of a solution with 32 mEq/L sodium. In the other four
cases, initial and follow-up serum sodium values were normal. None of
these children failed treatment.
Fig. 1.
Homemade cereal-based ORS sodium concentration.
[View Larger Version of this Image (16K GIF file)]
The distribution of sodium concentrations in the premixed packet
group is shown in Figure 2. There was one
mixing failure in this group (1/68 = 1.5% [one-sided upper limit
of 95% CI = 6.8%]). The mother reported that the child's
father had added salt to the mixture to improve its taste because the
child was refusing to drink it. The solution sample had a sodium
concentration of 138 mEq/L, the child was reported to have refused the
solution, and his follow-up serum sodium value was normal. One other
parent reported adding sugar to the mixture to improve its taste. The mean solution sodium concentration for the remainder of the group was
60 ± 10 mEq/L. Two parents mixed solutions with low sodium concentration (both were 23); in both cases, initial and follow-up serum sodium values were normal. Neither of these children failed treatment.
Fig. 2.
Packet cereal-based ORS sodium concentration.
[View Larger Version of this Image (15K GIF file)]
Serum Sodium Concentration
Mean serum sodium concentration was 139 ± 3.0 mEq/L at
enrollment and 139 ± 2.5 mEq/L at 24 to 48 hours' follow-up, and
did not differ significantly by treatment group. Considering all
children with enrollment and follow-up serum sodium determinations
(N = 169), 18 patients (11%) had abnormal serum sodium values at
enrollment. In all of these cases, serum sodium was determined for
study purposes and not because it was considered indicated by the
examining physician. Their follow-up sodium values returned to normal
in 89% of cases (Fig 3). Two children with
abnormal enrollment values and three children with normal enrollment
values had a follow-up serum sodium value that was abnormal, but none
were in the range defined as treatment failure and all were clinically
healthy at follow-up. No child with an abnormal serum sodium value on
reevaluation required hospitalization.
Fig. 3.
Abnormal serum sodium at enrollment (time 1) and at 24 to 48 hours
(time 2).
[View Larger Version of this Image (17K GIF file)]
Treatment Failures
Among children in the homemade CBORS group, there were three
treatment failures (4.5%, [one-sided upper limit of 95% CI = 11.3%]); two children were hospitalized. There were four treatment failures in the premixed packet CBORS group (6% [one-sided upper limit of 95% CI = 13%]); two were hospitalized. One child
failed treatment in the Pedialyte group (1.4% [one-sided upper limit of 95% CI = 6.7%]) and was hospitalized. These proportions are not significantly different (P = .39).
Oral Liquid Intake
Most parents did not maintain complete written records of oral
intake as requested, thus, daily recall was relied on to estimate quantitative liquid consumption. In the first 24 hours after
enrollment, 43% of the children in the homemade cereal ORS group did
not take any of the assigned solution, compared with 32% of those in
the packet group and 9% of those in the Pedialyte group (homemade vs
packet, P = .3; homemade vs Pedialyte,
P = .00003; packet vs Pedialyte, P = .003). This pattern remained consistent on most of the following 5 days
of illness. Children who took none of the cereal-based solutions in the
first 24 hours were not more likely to have been on Pedialyte at
enrollment nor to have had previous experience with Pedialyte. A total
of 21% of parents of children taking none of the cereal-based
solutions reported that they had not offered the child the study
solution. Among children who did not refuse ORS, those in the homemade
CBORS group consumed less ORS than those in the Pedialyte group on days
2 and 4 (Table 3). Among all children, those
in the homemade CBORS group consumed less total fluid than those in the
Pedialyte group on days 2 and 3, and less than those in the packet
group on day 2 (Table 4).
|
Table 3.
ORS Intake by Treatment Group (Median mL/kg/d)*
[View Table]
|
|
Table 4.
Total Fluid Intake by Treatment Group (Median mL/kg/d)
[View Table]
|
At the end of the child's illness, parents were asked their opinion of
the assigned solution. There were no significant differences among the
three groups in the proportion of parents who found the smell or
consistency of the solution to be unpleasant (8% to 13%), although
more parents found the color of the homemade (9%) and the packet
(15%) CBORS to be unpleasant compared with those assigned Pedialyte
(0%) (P = .0005). Perception of unpleasant qualities was not associated with the child's not taking the assigned solution, nor was the parents' perception that the CBORS was too thick
to serve (homemade 16%, packet 7%).
Vomiting, Stool Frequency, Duration of Illness, and Weight Gain
There were no differences by treatment group assignment in the
proportion of children vomiting per day for the first 7 days of illness
after enrollment, which ranged from 17% to 28% on day 1 and declined
thereafter, nor in median number of diarrheal stools, which ranged from
1 to 2. There were seven cases of diarrhea persisting >14 days
beyond enrollment: three in the homemade group, and two each in the
packet and Pedialyte groups. In all these cases, illness resolved in
the third week after enrollment. These cases were excluded from
analysis of duration of illness. Median duration of diarrheal illness
did not differ by treatment group: for children in the homemade CBORS
group, median duration (range) was 111 hours (7 to 335); for those in
the packet CBORS group, 97 hours (19 to 327); and for those in the
Pedialyte group, 92 hours (10 to 310).
Using 80% power with
= 0.05, and given the sample sizes and SDs
observed, we calculated that the smallest detectable difference between
group 1 and group 3 was 38 hours, and between group 2 and group 3, 39 hours. To assess potential therapeutic differences among the children
with the most severe disease, we repeated this analysis using only the
children in the upper tercile of ORS consumption in the first 24 hours
and, again, found no significant differences in proportion of children
vomiting, stool frequency, or duration of diarrhea. We obtained the
same results when we restricted the analysis to those in the upper
tercile of stool frequency on day 1, and again when we restricted
analysis to those children who were judged to be dehydrated at
presentation.
Between enrollment and end of illness, children gained a median of
0.180 kg (range,
0.125 to 1.83 kg), or 1.8% of enrollment (hydrated) weight, and between end of illness and 1 week follow-up, 0.200 kg (range,
0.55 to 1.54), or 2.0%. There were no differences in weight change among treatment groups.
DISCUSSION
Most parents in this low-income and multiethnic sample were able
to safely prepare CBORS both from ingredients commonly found in the
home and from a premixed packet (97% and 99%, respectively). However,
several potentially hazardous mixing errors were made, although in none
of these cases was there an adverse clinical outcome. Most other
reports of trials of homemade ORS preparation are from poor countries,
where wide ranges of accuracy in solution sodium concentration have
been found.18,22 Few such studies have been
reported from industrialized countries; studies from Italy25 and England26 have shown a high
variability of homemade sugar-salt ORS. The greater accuracy of the
parents in our study may be attributable to the fact that they had been
instructed personally in solution preparation by a nurse in addition to
having received written instructions.
Children were less likely to take the cereal-based than the
glucose-based solution. Median ORS and total fluid consumption reported
by parents were low for all three study groups; this might reflect
inaccurate reporting, because most parents did not adhere to
instructions to keep a written record of fluid intake. Nonetheless,
treatment failure rates were similarly low for the three treatment
groups and within the range of failure rates reported in other trials
of outpatient ORT in the United States.27 The three
solutions studied were found to be equally effective in maintaining
hydration and correcting both hypernatremia and hyponatremia. We did
not find any advantage in treatment outcome among children in the CBORS
groups compared with those assigned glucose-based ORS. This may have
been attributable to the relative mildness of illness in the children
studied. Furthermore, a recent metaanalysis has shown no significant
reduction in stool output in children with acute, noncholera diarrhea
given rice-based ORS.33,34 Thus, efforts to prevent the
morbidity and mortality of acute diarrheal disease in US children
should not be focused primarily on the use of cereal-based as opposed
to glucose-based ORS.
Whether using an ORS at the onset of illness is more effective in
preventing dehydration than simply increasing the child's usual fluids
is not known; the AAP practice parameter10 states that ORS
is not necessary for the child without dehydration, whereas the Centers
for Disease Control and Prevention recommends that "families with
infants and small children should be encouraged to keep a supply of ORS
at home at all times and use the solution when diarrhea first occurs in
the child."11 There are no data available to answer this
question. It is our clinical impression that the majority of children
with acute gastroenteritis will do well even without ORS, but there are
a minority of children who develop severe purging, especially with
rotavirus infection, and it is these children who will be most in need
of an appropriate ORS to maintain hydration and prevent
hyponatremia and hypernatremia. Our data show that homemade CBORS is
not the safest alternative, because it carries the risk of potentially
dangerous mixing errors even with the most careful supervision, and it
is likely that the children most severely affected with dehydrating
diarrhea would be most likely to consume, if offered, a mixture
erroneously prepared with too much salt. There are circumstances in
which homemade CBORS may be considered an option, eg, in the case of a
young child with rapid purging whose family is unable to obtain commercial ORS and is in telephone contact with a clinician who has
confidence in their ability to prepare the solution correctly.
The packet-reconstituted CBORS was diluted correctly in all cases,
although errors in preparation can still be made, especially by the
addition of extra ingredients to the ORS (as occurred in two cases in
our study), which can also occur with a premixed commercial solution
such as Pedialyte. A premixed packet for reconstitution with water may
represent the most practical way to ensure that families at highest
risk have ORS on hand when the need arises. Such packets could be
distributed readily at primary care facilities, although the cost might
need to be subsidized to remove the economic barrier standing between
poor families and ORT.a
FOOTNOTES
Dr Sampson is currently at the Perinatal Epidemiology Unit, Department
of Epidemiology and Public Health, Yale University School of Medicine,
New Haven, CT.
Dr Dixit is currently at the Department of Human Nutrition and
Dietetics, University of Illinois at Chicago, Chicago, IL.
a Glucose-based ORS packets may be
obtained from Pharmacia & Upjohn, Kalamzoo, MI 49001 (KaoLectrolyte)
and Jianas Brothers Packaging Co, Kansas City, MO (World Health
Organization ORS). CBORS packets are available from Cera Products Inc,
8265I Patuxent Range Rd, Jessup, MD 20794 (CeraLyte).
Received for publication Oct 29, 1996; accepted May 21, 1997.
This work was presented, in part, at the Ambulatory Pediatric
Association Annual Meeting, Washington, DC, May 9, 1996.
Reprint requests to (A.M.) Department of Pediatrics, Boston
Medical Center, Boston, MA 02118.
ACKNOWLEDGMENTS
This study was funded jointly by the Agency for Health Care
Policy and Research and the Child Health Foundation (Columbia, MD)
Grant R01 HS08335-01.
We thank the nursing and medical staffs of Boston City Hospital, Boston
Children's Hospital, Codman Square Neighborhood Health Center,
Whittier Street Neighborhood Health Center, Upham's Corner Health
Center, Dimock Street Neighborhood Health Center, Martha Elliott Health
Center, South End Neighborhood Health Center, and Mattapan Health
Center for their collaboration and support. We also thank the study
nurses
Marie Graham, Jacqueline LaGuerre, Mary Lenihan, Robert
Marrero, Ann-Marie McCarthy, Gertrude Monestime, and Caridad
Ramirez
for their excellent nursing care and diligent attention; Dr
Ronald Kleinman for his review of the study design and monitoring of
safety data; and Dr Adrienne Cupples, Suzette Levinson, and Dr Robert
Houser for statistical advice and calculations.
ABBREVIATIONS
ORT, oral rehydration therapy.
ORS, oral rehydration
solutions.
CBORS, cereal-based oral rehydration solutions.
CI, confidence interval.
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