Journal of Pediatric Gastroenterology and Nutrition
44:354358 # 2007 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and
North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition
Randomized, Controlled Trial of Early Intravenous Nutrition for
Prevention of Neonatal Jaundice in Term and Near-term Neonates
zer, Abdullah Kumral, Didem Yesilirmak, and Hasan O
Balahan Makay, Nuray Duman, Esra O
Department of Pediatrics, Division of Neonatalogy, Dokuz Eylul University Hospital, Izmir, Turkey
ABSTRACT
Background: This study was undertaken to investigate the
effects of early parenteral nutrition on prevention of neonatal
jaundice in term and near-term neonates who could not be
enterally fed.
Patients and Methods: Seventy-two infants were randomized
into 2 groups: the early parenteral nutrition group (group 1)
received 1.0 g/kg/d amino acids beginning within the first day
and 1.0 g/kg/d lipid added the next day. The conventional
nutrition group (group 2) started on a solution containing
10% glucose and electrolytes in the first 72 hours of life,
followed by 0.5 g/kg/d amino acids and lipid. Amino acids
and lipid were each increased by 0.5 g/kg/d to a maximum of
3.0 g/kg/d in both groups. Main outcome measures were energy
intake; serum bilirubin levels at 24, 48, and 72 hours; need for
phototherapy; and duration of phototherapy.
Results: Higher energy intake was achieved after the first day in
group 1. Daily serum bilirubin levels did not significantly differ
INTRODUCTION
In some newborn infants, enteral feeding cannot be
commenced immediately after birth. Therefore, the
institution of enteral feeding may be delayed for many
days and energy support is provided by intravenous
solutions. Traditionally, such solutions initially contain
only glucose and subsequently amino acids and lipid
emulsion gradually introduced toward the end of the first
week of life. However, in recent years, early parenteral
nutrition was proven to be safe in preterm infants with a
positive impact on survival and long-term well-being
(14). Early introduction of enteral feeding was shown
to decrease the severity and duration of neonatal jaundice
(5,6). In many studies, the cause of this decrease was
proven to be a reduction in intestinal transit time with a
resulting decrease in enterohepatic circulation of bilir-
Received August 4, 2006; accepted October 3, 2006.
Address correspondence and reprint requests to Balahan Makay, MD,
Dokuz Eylul University Hospital, Department of Pediatrics, 35340
Balcova-Izmir, Turkey (e-mail: bboramakay@yahoo.co.uk).
354
Copyright 2007 by Lippincott Williams & Wilkins.Unauthorized reproduction of this article is prohibited.
zkan
between groups. Nine patients in each group required
phototherapy. The initiation times of phototherapy were
92.9 hours
25.5 in group 1 and 83.1 hours
28.5 in group 2.
Durations of phototherapy were 37.3 hours
11.1 in group 1
and 52.0 hours
20.7 in group 2. There were no significant
differences in the requirement, initiation time, and duration
of phototherapy.
Conclusions: Early parenteral nutrition has no proven
benefit in terms of therapy requirement or severity and
duration of neonatal jaundice compared with conventional
parenteral nutrition in term and near-term infants who
could not be enterally fed. JPGN 44:354358, 2007.
Key Words: Early parenteral nutritionIndirect hyper-
bilirubinemiaNewborn. # 2007 by European Society for
Pediatric Gastroenterology, Hepatology, and Nutrition and
North American Society for Pediatric Gastroenterology,
Hepatology, and Nutrition
ubin (7,8). However, the effect of early intravenous
nutrition on neonatal jaundice remains unknown (9).
In this randomized study early parenteral feeding was
compared with routine intravenous solutions to investigate
its effects on severity and duration of neonatal jaundice in
term and near-term neonates. Until now, the studies
designed to investigate effects and tolerability of early
parenteral nutrition were performed only in preterm
infants. In addition, these studies did not primarily aim
to determine the impact of early parenteral nutrition on
prevention of neonatal jaundice. To our knowledge, this is
the first study that investigates effects of early parenteral
nutrition on bilirubin levels in term and near-term infants.
PATIENTS AND METHODS
This prospective study was performed at our institution
between October 2003 and July 2006. During the study period,
all singleton newborns with a gestational age of 35 weeks and
whose clinical condition seemed to preclude oral feeding for a
period of 3 days consecutively enrolled after informed
parental consent had been obtained. Infants with major
congenital anomalies and/or perinatal factors associated with
 RCT OF EARLY IV NUTRITION FOR PREVENTION OF JAUNDICE
an increased risk of hyperbilirubinemia, including maternal
diabetes mellitus, polycythemia, perinatal asphyxia, hypother-
mia, cephalohematoma, intracranial hemorrhage, or perinatal
infection were not eligible for the study. Infants with 35 to 37
weeks of gestation were defined as near-term, whereas those
with 37 completed weeks of gestation were defined as term.
The protocol was approved by the ethics committee of the
faculty.
At entry into the study, complete blood count, peripheral
blood smear, blood glucose, blood gas, blood culture, C-reactive
protein levels, and chest radiography were routinely performed.
Frequency of blood gas and blood glucose analysis was
determined according to patients clinical conditions.
All of the infants who met inclusion criteria were randomly
allocated to receive 1 of 2 intravenous nutrition regimens: the
early parenteral nutrition group (group 1) received 1.0 g/kg/d
amino acids (TrophAmine 6%; B. Braun, Melsungen, Germany)
started within the first 8 hours after birth and 1.0 g/kg/d lipid
(intralipid 20%) the next day. In the conventional nutrition group
(group 2), fluid regime was started with glucose 10% in the first
day of life followed by glucose and electrolyte solution and added
amino acids (0.5 g/kg/d) and lipid (0.5 g/kg/d) on the third and
fourth day, respectively. Amino acids and lipid were each
increased by 0.5 g/kg/d to a maximum of 3.0 g/kg/d in both
groups. Peripheral vein catheterization was used for parenteral
nutrition as well as for the administration of other fluids and
therapy. Lipids were administered from a separate catheter over a
period of 24 hours. The planned intakes of the 2 regimens were
isovolumetric. Term infants received daily maintenance fluid
levels of 60 mL/kg on day 1 and 90 mL/kg on day 2, whereas
near-term infants received 80 and 100 mL/kg on days 1 and 2,
respectively. All of the infants received 120 mL/kg fluid on day 3
and 150 mL/kg from day 4 of life onward. If clinically indicated,
fluid intakes were altered by clinicians responsible for the care of
the infants. The patients were administered peroral feeding when
the respiratory frequency consistently decreased to 60/min.
Parenteral feeding was continued until full enteral feeding
was accomplished.
Capillary total bilirubin levels were measured at 24, 48, and
72 hours of life and then repeated at certain intervals if clinically
indicated. Total bilirubin levels were measured by the spectro-
photometric method. Phototherapy was applied according to
our clinical protocol of hyperbilirubinemia for term infants
(Table 1) (10,11). If infants birth weight was <2500 g, then
serum threshold bilirubin levels for starting phototherapy
were 13 mg/dL for healthy infants and 12 mg/dL for sick
ones (12). Direct Coombs test, blood typing, reticulocyte count,
and glucose-6-phosphate-dehydrogenase measurements were
performed additionally if the infant required phototherapy.
TABLE 1. Threshold serum bilirubin levels (mg/dL) for
starting phototherapy with respect to postnatal age in healthy
and sick term infants
Postnatal age, h Healthy Sick
<24 1012 710
2548 1215 1012
4972 1518 1215
>72 1820 1215

Data adapted from references 10 and 11.
Copyright 2007 by Lippincott Williams & Wilkins.Unauthorized reproduction of this article is prohibited.
355
Infants were excluded who had known risk factors such as
blood group incompatibilities, positive Coombs test findings,
glucose-6-phosphate-dehydrogenase deficiency, or any labora-
tory evidence of hemolytic disease as evidenced by anemia,
reticulocytosis, or abnormality of the blood smear. In addition,
patients who had positive C-reactive protein and blood culture,
leukocytosis and pneumonic infiltration on the chest radiograph
(which are consistent with infection) and patients who could be
given enteral feeding in the first 48 hours of life were also
excluded from the study.
On the third day, serum blood sodium, potassium, chloride,
calcium, phosphorus, urea nitrogen, creatinine, total and direct
bilirubin, triglyceride, alanine aminotransferase, alkaline
phosphatase, and albumin levels were assessed. These analyses
were performed in the clinical chemistry laboratory of the
hospital according to standard methods. Body weights were
determined daily on an electronic scale. The timing of first stool
output was noted. The number of stools was also recorded daily.
The main outcome measures were energy intake; changes in
body weight; time of first stool production; number of daily stool
output; relative changes in serum bilirubin levels at 24, 48, and
72 hours; need for phototherapy; and duration of phototherapy.
Statistical Analysis
Results are expressed as mean
SD. The Mann-Whitney U
test was used for nonnormally distributed variables, whereas the
Yates x2 test and Fisher exact test were used for nominal
variables. A P value <0.05 was considered significant. Pearson
bivariate correlation analyses were used to determine the cor-
relation between venous and capillary total bilirubin levels at
the third day.
RESULTS
Of 72 infants who entered the study, 18 were
withdrawn for several reasons such as positive direct
Coombs test findings (n 7), intracranial hemorrhage
(n 1), and introduction of enteral feeding in the first
48 hours of life (n 10), leaving 30 patients in group 1
and 24 patients in group 2. Three patients were diagnosed
with respiratory distress syndrome (RDS), whereas the
others were diagnosed with transient tachypnea of the
newborn (TTN). Eighteen patients were near-term, 4 of
whom had a birth weight <2500 g. There were no
significant differences demonstrated in mean birth
weight, gestational age, 5-minute Apgar score, mode
of delivery, or male/female and term/near-term ratios
in both groups. The patient characteristics of both groups
are shown in Table 2.
There was no difference in energy intake at the first day
of life, whereas significantly higher energy intake was
achieved at the second and third days of life (Table 3). The
mean of daily volume intake did not differ significantly
between groups. There was no statistical difference
between groups concerning the weight loss observed in
the first, second, or third days of life. The patients experi-
enced a mean weight loss of 4.6% in the first 3 days of life.
J Pediatr Gastroenterol Nutr, Vol. 44, No. 3, March 2007
 356 MAKAY ET AL.

TABLE 2. Demographic characteristics of early and TABLE 4. Daily serum total bilirubin levels, number of
conventional parenteral nutrition groups patients required phototherapy, initiation time of phototherapy,
and duration of phototherapy in both groups
Demographics Group 1 Group 2 P value
 Group 1 Group 2 P value
Gestational age, wk 37.3
1.5 37.1
1.3 0.7

Birth weight, g 2949.0
423.7 3167.3
428.7 0.07 Serum bilirubin, mg/dL

5-min Apgar score 9.0
0.8 9.2
0.8 0.3 Day 1 4.6
2.4 4.7
2.7 0.86
Sex (M/F) 17/13 10/14 0.2 Day 2 6.6
2.7 6.8
3.1 0.79
Delivery mode (cesarean/ 25/5 16/8 0.3 Day 3 8.5
3.3 8.7
3.3 0.79
vaginal) No. of patients required 9/21 9/15 0.57
Near-term/term ratio 10/20 8/16 1.0 phototherapy, yes/no

Initiation time of phototherapy, h 92.9
25.5 83.1
28.5 0.45
 
Values given as mean
SD. Duration of phototherapy, h 37.3
11.1 52.0
20.7 0.08

Values given as mean
SD.
Time of initiating enteral feeding and time needed for
reaching full enteral feeding were similar in groups 1 and 2
(P 0.8 and P 0.5, respectively). There was no differ- neonatal jaundice compared with conventional parenteral
ence between groups in time of first stool production, nor nutrition in term and near-term newborns.
in the number of stools produced daily (data not shown). Bilirubin metabolism is affected by energy intake.
Groups 1 and 2 did not differ significantly in bilirubin Energy restriction was shown to decrease the activity
levels during the first 24, 48, and 72 hours of life. Eighteen of UDP-glucuronyl transferase and hepatic uptake of
of 54 patients (34%) developed hyperbilirubinemia requir- bilirubin in adult and animal studies (1316). With this
ing phototherapy. There were no significant differences in study, we aimed to determine how greater energy support
number of patients who required phototherapy, nor in the provided by early parenteral nutrition affects develop-
initiation time and duration of phototherapy between ment of neonatal jaundice when compared with conven-
groups 1 and 2 (Table 4). No significant difference between tional parenteral nutrition. Despite the provision of
groups was determined concerning the biochemical additional energy support, no significant differences were
analysis performed on the third day (data not shown). demonstrated in bilirubin levels at the first 3 days,
The venous total bilirubin and capillary bilirubin levels on phototherapy requirement, time of initiation of photo-
the third day showed significant correlation (r 0.89; therapy, and duration of phototherapy between 2 feeding
P < 0.001), proving the accuracy of the spectrophoto- regimens. Therefore, we found that sufficient energy
metric method. unit intake for the energy-dependent steps of bilirubin
metabolism may also be provided by routine intravenous
DISCUSSION fluid administration.
The route of nutrition was shown to be important to
Parenteral nutrition is commonly used in newborn bilirubin metabolism in several studies. It was reported that
infants who cannot be enterally fed, and it is often initiated glucose given orally immediately reversed the hyperbilir-
after the first few days of life at a time when unconjugated ubinemia observed after fasting, although equimolar
hyperbilirubinemia is almost invariably present. Although amounts of glucose given intravenously did not affect
early parenteral nutrition may be expected to result in the bilirubin levels in healthy individuals and patients with
lower levels of unconjugated bilirubinemia much like Gilbert syndrome (17,18). In a study by Waters et al (19), in
early enteral feeding, no controlled studies have been which some swine underwent energy restriction, hepatic
published primarily investigating this potential benefit. clearance of indocyanine green, which was an indicator of
In this prospective and randomized study, early parenteral bilirubin clearance, improved by enteral refeeding,
nutrition was shown to have no proven benefit on the whereas parenteral feeding failed to improve indocyanine
phototherapy requirement or severity and duration of green clearance. The hyperbilirubinemia induced by a
controlled-energy diet is not modified when adequate
energy supplement is given intravenously, thus raising
TABLE 3. Energy intakes of patients according to postnatal the question whether an intestinal step is necessary for
days (kcal/kg/d) the control of the phenomenon. In our study, there was no
Group Day 1 Day 2 Day 3 control group of patients who received enteral feeding.
Besides, it is known that early enteral feeding decreases
Early parenteral nutrition 23.7
5.1 35.5
4.3 47.8
6 the enterohepatic circulation of bilirubin by lowering
Conventional parenteral 22.4
3.8 29
4.8 37.4
4.7
nutrition
the intestinal transit time (8,9). Gourley et al (20)
P value 0.33 0.000 0.000 demonstrated that the faster the infants meconium was
removed and the more frequent the stool output, the lower

Values given as mean
SD. the serum bilirubin levels were in mothers milkfed

J Pediatr Gastroenterol Nutr, Vol. 44, No. 3, March 2007

Copyright 2007 by Lippincott Williams & Wilkins.Unauthorized reproduction of this article is prohibited.
 RCT OF EARLY IV NUTRITION FOR PREVENTION OF JAUNDICE
infants in the first 3 weeks of life. Salariya and Robertson
(21) also showed in 150 healthy full-term infants that
hyperbilirubinemia was less frequent in the neonates in
whom the meconium was removed rapidly. We could not
find a significant difference between groups in the time of
first stool output and daily number of stools, which may be
indicators of intestinal transit time. Therefore, it can be
concluded that early parenteral nutrition does not have any
effect on intestinal transit time.
In a recent study, Mehta et al (22) demonstrated the
efficacy of extra fluid supplementation in decreasing the
rate of exchange transfusion and the duration of photo-
therapy in term neonates with severe hyperbilirubinemia.
They gave 50 mL/kg of N/5 saline solution in 5% dextrose
for 8 hours and offered 30 mL/kg/d extra oral feeding to the
study group, whereas the control group continued to
receive oral feeding ad libitum. In our study, the fluid
intakes of the 2 groups were isovolumetric and no extra
fluid was loaded. Adequate weight gain is also an
important factor influencing neonatal hyperbilirubinemia.
The patients experienced a mean weight loss of 4.6% in the
first 3 days of life, which is not more than the rate expected
to enhance hyperbilirubinemia.
Although the frequency of hyperbilirubinemia did not
differ between groups, a total of 34% of infants needed
phototherapy. This rate was also high (28%) even when the
term infants were evaluated separately. Several popu-
lation-based studies reported the incidence of pathological
hyperbilirubinemia as 10% to 13% in healthy term infants
(23,24). The exclusion of patients with pathological
hyperbilirubinemia at the beginning of the study makes
this high rate important. The phototherapy limits of our
clinical protocol throughout the study period were gener-
ally more conventional according to the recent guidelines
of the American Academy of Pediatrics (10,25). Another
contributor to this high rate may be the fact that these
infants were accepted as being at high risk and given
phototherapy at lower levels because of their primary
illnesses, TTN and RDS. However, the lack of enteral
feeding, at least in the first 3 days of life, was considered to
be the most important factor in development of hyperbi-
lirubinemia in this study.
The primary illnesses of the patients, TTN and RDS,
may contribute to hyperbilirubinemia, but no direct associ-
ation was found between hyperbilirubinemia and these
diseases. However, heme oxygenase-1 is the rate-limiting
step of heme degradation with proven cytoprotective
facilities and thus can be induced by hypoxia (26,27).
To the contrary, in case of an oxidative stress such as
hypoxia, it was shown that a decrease in plasma bilirubin
was contemporaneous with an increase in plasma antiox-
idant capacity to decrease the oxidative stress in preterm
infants (28). In our study, the objective indicators of
heme oxygenase-1 activity such as end-tidal carbon
monoxide or serum carboxyhemoglobin levels were not
measured.
Copyright 2007 by Lippincott Williams & Wilkins.Unauthorized reproduction of this article is prohibited.
357
Free fatty acids may influence the indirect bilirubin
levels by competing with indirect bilirubin for binding to
the same receptors on albumin. Spear et al (29) evaluated
the effect of 15-hour fat infusions of varying dosage (1, 2,
and 3 g/kg) on bilirubin binding to albumin. They
observed significant increases in free fatty acid/albumin
ratio in infants of <30 weeks gestation, but not in infants
30 weeks gestation. In a study by Rubin et al (30), no
correlation was found between free fatty acids and
free bilirubin in premature neonates who were given
intravenous fat emulsions over a period of 1620 hours.
Regarding these studies, it is believed that the lipid
doses used in our study may have little effect on bilirubin
levels.
Recently, a randomized controlled study including
infants with low birth weight revealed that the mean
peak serum bilirubin level was significantly higher in
early parenterally fed infants compared with late parent-
erally fed ones, without any clinical difference between
both groups (31). In a study by Murdock et al (32), peak
mean bilirubin concentrations and the need for photo-
therapy were demonstrated to be similar in the early and
late parenteral nutrition groups. Both studies were carried
out in low birth weight preterm infants and primarily
aimed to investigate the tolerability of early parenteral
nutrition, however.
In conclusion, this preliminary study suggests that
early parenteral nutrition in term and near-term newborns
who cannot be fed enterally in the first days of life has no
proven benefit on the therapy requirement or severity and
duration of neonatal jaundice. Further clinical trials and
large series investigating the effect of early parenteral
nutrition on prevention of neonatal jaundice in term and
near-term infants, as well as preterm infants, are required.
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