Digestive and Liver Disease 37 (2005) 432–438

Alimentary Tract

Gastrointestinal symptoms in infancy: A population-based

prospective study
G. Iacono a , R. Merolla b , D. D’Amico a , E. Bonci c , F. Cavataio a , L. Di Prima d ,
C. Scalici a , L. Indinnimeo c , M.R. Averna d , A. Carroccio d,∗
the Paediatric Study Group on Gastrointestinal Symptoms in Infancy1
a Paediatric Gastroenterology, ‘Di Cristina’ Hospital of Palermo, Italy
b Medical Department, ABBOTT, Italy
c Paediatric Department, University of Rome ‘La Sapienza’, Italy
d Internal Medicine, University Hospital of Palermo, via Coffaro 25, Palermo 90124, Italy

Received 23 August 2004; accepted 17 January 2005

Available online 2 March 2005

Abstract

Background. During the first months of life, infants can suffer from many ‘minor’ gastroenterological disturbances. However, little is
known about the frequency of these problems and the factors which predispose or facilitate their onset.
Aims. (a) To ascertain the frequency of the most common gastrointestinal symptoms in infants during the first 6 months after birth; (b) to
evaluate the influence of some variables on the onset of the symptoms.
Study design and patients. Each of the 150 paediatricians distributed throughout Italy followed 20 consecutive infants from birth to 6
months. 2879 infants (1422 f, 1457 m) concluded the study. The presence of the following symptoms was evaluated: constipation, diarrhoea,
vomiting, regurgitation, failure to thrive and prolonged crying fits (colic). Symptoms were recorded whenever the parents requested a clinical
check-up or during a set monthly examination.
Results. 1582/2879 (54.9%) infants suffered from one of the gastrointestinal symptoms. Regurgitation was the most common disturbance
(present in 23.1% of infants), followed by colic (20.5%), constipation (17.6%), failure to thrive (15.2%), vomiting (6%) and diarrhoea (4.1%).
Low birth weight was the factor most frequently associated with the onset of gastrointestinal symptoms, followed by low gestational age.
Feeding habits did not influence the onset of symptoms, with the exception of constipation, which was linked to a low frequency of breast-
feeding. Ninety-three infants (3.2%) were hospitalised for one or more of the gastrointestinal symptoms which were considered. During the
whole study period the type of formula-milk was changed in 60% of the infants with one or more gastrointestinal symptoms, and in 15.5%
of the infants who did not suffer from any gastrointestinal troubles.
Conclusions. Gastrointestinal symptoms are very common in infants during the first 6 months after birth. These symptoms required
hospitalisation only in a small percentage of cases, but led to the prescription of a ‘dietary’ milk formula in approximately 60% of the cases.
Low birth weight and low gestational age were the main factors influencing the onset of the symptoms.
© 2005 Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.

Keywords: Colic; Constipation; Diarrhoea; Epidemiology; Failure to thrive; Feeding; Infancy; Regurgitation; Vomiting

1. Introduction

During the first months after birth our gastrointestinal sys-

∗ Corresponding author. Tel.: +39 091 6552860; fax: +39 091 6552936.
tem strives to adapt itself to the various nutrients in order
E-mail address: liwcar@tin.it (A. Carroccio). to perfect its digestive, absorptive and immunological func-
1 See Appendix A. tions. Obviously, during this ‘stressful’ period infants can suf-

1590-8658/$30 © 2005 Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.
doi:10.1016/j.dld.2005.01.009
 G. Iacono et al. / Digestive and Liver Disease 37 (2005) 432–438
fer from many gastroenterological disturbances, which in the
majority of cases are dealt with by paediatricians without the
need for hospitalisation and/or laboratory/instrumental inves-
tigations. However, little is known about the real frequency of
these ‘minor’ gastrointestinal disturbances, the factors which
predispose or facilitate their onset and the relationship be-
tween these disturbances and the type of feeding the infants
receive.
The aims of the present prospective, population-based
study were: (a) to ascertain the frequency of the most com-
mon gastrointestinal symptoms in infants during the first 6
months after birth; (b) to evaluate the influence that some
variables have on the onset of these symptoms; (c) to clar-
ify the causes for hospitalisation due to gastrointestinal
disturbances.
2. Patients and methods
2.1. Study design
The study was carried out between January and December
1999 with the collaboration of 150 paediatricians distributed
throughout Italy (40 in the north of Italy, 35 in the centre,
40 in the south and 25 in the islands). In accordance with
the Italian Health Organisation regulations for the assistance
of infants, parents are required to choose a paediatrician im-
mediately after the childbirth to be able to receive adequate
primary assistance in case of illness or, simply, to monitor the
regular development of infants. The paediatricians involved
in the present study were asked to record the presence of gas-
trointestinal symptoms in the first 20 infants to be registered
with them during the study period. The data were recorded
from the moment the infant was registered up to the age of 6
months.
Inclusion criteria were: (a) age at entry to the study of less
than 2 weeks; (b) absence of any disease diagnosed before
entry to the study. Consequently, infants older than 2 weeks
and those with a definite diagnosis of gastroenterological,
respiratory, urinary, neurological or metabolic disease were
excluded.
Data were collected using a standard clinical chart which
included: date of birth, sex, weight and height at birth, gesta-
tional age, mother’s age and father’s level of education, type
of feeding (bottle, breast or mixed). Furthermore, following
the medical visits, the paediatricians reported the presence
of the following symptoms: constipation, diarrhoea, vom-
iting, regurgitation, failure to thrive and prolonged crying
fits (colic). Symptoms were recorded whenever the parents
requested a clinical check-up or, in any case, during a set
monthly visit.
Hospitalisation or feeding changes following the onset of
any of the above symptoms were recorded.
Constipation was defined as chronic faecal retention char-
acterised by one bowel movement every 3 days or more, of-
ten associated with crying fits. Diarrhoea was defined as the
433
number of daily bowel movements higher than the 97th per-
centile for bowel frequency recorded in healthy age-matched
infants [1], with very liquid stools. Consequently, the up-
per limit was six evacuations/day within the first month of
life, and 4.5 evacuations/day between the second and sixth
months [1]. Vomiting was defined as the loss of a consistent
part (about 50% or more) of the previous meal, after retch-
ing. Regurgitation was defined as the loss of a small part of
the meal, without retching. Failure to thrive was defined as
the weight growth of less than 400 g/month, or a decrease in
the weight/height curve compared with the previous medical
examination. Colic was defined as prolonged fits of crying,
without apparent reason, with a mean daily duration of over
3 h, for more than 3 days/week during the previous 2 weeks
[2], accompanied by swelling of the abdomen due to intesti-
nal gas and sleep disturbances.
Twenty-five clinical monitors visited the paediatricians in-
volved in the study each month to help them compile the
clinical charts and to ensure that the data were correctly
recorded according to the study protocol definitions. Fur-
thermore, close telephone contact between the paediatricians
and the monitors was ensured during the whole period of the
study.
2.2. Patients
According to the study design, a total of 3000 infants were
initially included in the study; however, only 2879 concluded
the 6-month period of the study. In fact, the remaining 121
infants were lost from the study as they moved out of the
original geographical area (72 cases) or decided to change
paediatricians (49 cases).
At the time of entry to the study, mean age (±S.D.) of
the 2879 infants who concluded the study (1422 f, 1457 m)
was 10.1 ± 2.2 days (range 7–13 days). Mean birth weight
was 3263 ± 455 g (range 2100–5000 g). Mean gestational age
was 39.1 ± 1.4 weeks (range 32–43 weeks). Mean mother’s
age was 29.7 ± 4.7 years (range 14–50 years). The father’s
level of education was: 4% primary school, 38% lower sec-
ondary school, 43% upper secondary school and 15% had
a university degree. As regards the type of feeding at entry
to the study, 2332 infants (81%) were breast-fed, 230 (8%)
were mixed-fed and 317 (11%) were bottle-fed. However,
during the study period many infants changed their feeding
habits, with a progressive reduction in exclusively breast-fed
and an increase in mixed- or bottle-fed subjects. Infants who
changed feeding habits during the study period, before the
onset of a symptom, were included in the analysis only if the
symptom appeared at least 2 weeks after the beginning of the
new regimen. Consequently, in evaluating the relationship
between the type of feeding and symptoms, we considered
‘breast-fed’ those infants exclusively breast-fed until the on-
set of a symptom, ‘mixed-fed’ those mixed-fed from at least
2 weeks to the onset of a symptom and ‘bottle-fed’ those ex-
clusively fed with an adapted milk formula from at least 2
weeks.
434 G. Iacono et al. / Digestive and Liver Disease 37 (2005) 432–438
No standard guidelines were drawn up to establish the
reasons or the time for changes in milk formulas. The paedi-
atricians decided on and suggested a change in formula milk
whenever they considered it necessary, both in the presence of
gastrointestinal or extra-gastrointestinal symptoms and also
for different reasons. The parents of all the infants gave their
informed consent to the study and it was approved by the
Ethics Committee of the University Hospital of Palermo.
3. Statistical analysis
The frequency of each symptom was calculated and ex-
pressed as a percentage of the total number of infants included
in the study. For each symptom Student’s t-test was used to
compare mean values of birth weight, gestational age and
mother’s age in the patients with a specific symptom versus
all the others without that symptom. Furthermore, the rele-
vance of the low birth weight and the gestational age was eval-
uated using the χ2 -test; in fact, we compared the frequency
of infants with birth weight <2500 g or with gestational age
<36 weeks in the patients with a specific symptom versus all
the others without that symptom. The same test was used to
compare the frequency of the different levels of education of
the father and the type of milk feeding in the infants with a
specific symptom and in those without that symptom.
The χ2 -test was also used to compare the frequency of
hospitalisation in the infants with a symptom versus those
without that symptom. P-values <0.05 were considered sig-
nificant.
4. Results
During the study period 1582/2879 (54.9%) infants suf-
fered from one of the gastrointestinal symptoms which we
scheduled. Regurgitation was the most common disturbance
(present in 664/2879 infants, 23.1%), followed by colic (589
cases, 20.5%), constipation (507 cases, 17.6%), failure to
thrive (439 cases, 15.2%), vomiting (174 cases, 6%), di-
arrhoea (117 cases, 4.1%). A single symptom was present
in 966 subjects (61.1% of the patients with gastrointesti-
nal symptoms), two symptoms were present in 417 (26.3%),
three in 140 (8.8%), four in 50 (3%) and five in 14 (0.8%).
4.1. Factors associated with each symptom
Regurgitation was present in 334 males and 330 females.
It was diagnosed at a mean age (±S.D.) of 32 ± 25 days.
Infants with regurgitation had a lower birth weight and ges-
tational age than those without this symptom (3213 ± 461 g
versus 3279 ± 453 g; t = 3.24; P < 0.001 for birth weight;
38.98 ± 1.36 weeks versus 39.17 ± 1.48 weeks; t = 2.79;
P < 0.005 for gestational age). Furthermore, in the infants
with birth weight lower than 2500 g, the frequency of regur-
gitation was higher than in all the other infants (30.6% ver-
sus 22.9%; χ2 = 3.8; P < 0.05). No difference was observed
as regards mother’s age, father’s level of education and type
of feeding.
Colic was present in 589/2879 infants (279 males and 310
females). It was diagnosed at a mean age (±S.D.) of 31 ± 21
days. There was no difference in the parameters considered
in this study between infants with colic and those without this
symptom.
Constipation was present in 507/2879 infants (252 males
and 255 females). It was diagnosed at a mean age (±S.D.)
of 33 ± 27 days. Infants with constipation did not differ from
those without this symptom in terms of birth weight, ges-
tational age, mother’s age and father’s level of education;
however, there was a significantly lower frequency of breast
feeding than in infants without constipation (76.3% versus
84.9%; χ2 = 9.9; P = 0.007).
Failure to thrive was recorded in 439/2879 infants (182
males and 257 females). It was observed at a mean age
(±S.D.) of 59 ± 42 days. The infants with low growth
had a lower birth weight than all the other study subjects
(3174 ± 449 g versus 3280 ± 455 g; t = 4.502; P < 0.001).
There was no difference in any of the other parameters eval-
uated between the subjects with failure to thrive and those
with normal growth.
Vomiting was present in 174/2879 infants (84 males and
90 females). This symptom was diagnosed at a mean age
(±S.D.) of 43 ± 30 days. The infants with vomiting had a sig-
nificantly lower birth weight than all the others included in the
study (3200 ± 451 g versus 3270 ± 445 g; t = 1.95; P < 0.05).
Furthermore, the frequency of vomiting in infants with birth
weight lower than 2500 g was higher than in all the other
infants (10.2% versus 6%; χ2 = 3.5; P < 0.05). There was no
difference between them and all the other infants for any of
the other parameters evaluated.
Diarrhoea was present in 117/2879 infants (55 males and
62 females). This symptom was diagnosed at a mean age
(±S.D.) of 60 ± 41 days. The infants with diarrhoea had a
lower gestational age than all the other infants (38.71 ± 1.71
weeks versus 39.15 ± 1.44 weeks; P < 0.002), and the fre-
quency of diarrhoea in infants with gestational age below 36
weeks was higher than in all the other infants (14.6% versus
3.9%; χ2 = 12.1; P < 0.01). In all the other parameters consid-
ered (birth weight, mother’s age, father’s level of education
and type of feeding) there were no differences between in-
fants with diarrhoea and those without.
Table 1 summarises the association between each symp-
tom observed during the study and the variables considered
as possible causal factors. Low birth weight appeared to be
the most common influencing factor in determining the onset
of gastrointestinal symptoms.
4.2. Frequency and causes of hospitalisation
During the study period, 93 infants (3.2% of the infants in-
cluded in the study: 50 males, 43 females) were hospitalised
for one or more of the gastrointestinal symptoms we consid-
 G. Iacono et al. / Digestive and Liver Disease 37 (2005) 432–438
Table 1
Association between the presence of symptoms and the variables considered in the study
Regurgitation Colic
(N = 664) (N = 589)
Sex N.S. N.S.
Low birth weight P < 0.001 N.S.
Low gestational age P < 0.005 N.S.
Mother’s age N.S. N.S.
Father’s level of education N.S. N.S.
Type of feeding N.S. N.S.
For each symptom the patients suffering from that symptom were compared with all the other subjects included in the study. A total of 2879 infants were
studied.
a Infants with constipation showed a lower frequency of breast-feeding than the infants without constipation: 76.3% versus 84.9% (χ2 = 9.9; P = 0.007).
ered. Mean age at hospitalisation was 50 ± 27 days. A single
symptom caused hospitalisation in 35/93 cases, two asso-
ciated symptoms in 49/93 infants, three symptoms in 5/93
cases, four in 2/93 cases and five in 2/93 cases.
Fig. 1 shows the frequency of each symptom as the cause
of hospitalisation. In view of its high frequency in our study
population, regurgitation was the most frequent symptom in
the hospitalised patients. However, only 6.2% of the infants
with regurgitation were hospitalised (frequency of hospitali-
sation in patients with regurgitation versus all the other infants
included in the study: P = 0.026). Furthermore, hospitalisa-
tion was necessary in 5.8% of the infants with colic (P < .0001
versus all the other infants), 7.5% of the infants with failure
to thrive (P < 0.001 versus all the other infants), 12.1% of
the infants with vomiting (P < 0.0001 versus all the other in-
fants), 14.5% of the infants with diarrhoea (P < 0.0001 versus
all the other infants) and 3.9% of the infants with constipation
(difference not significant versus all the other infants).
Finally, as regards the influence of the gastrointestinal
symptoms in determining a change in feeding, we recorded
that during the whole study period the type of milk feeding
was changed in 1152/2879 (40%) on the advice of the pae-
diatrician. In detail, a change of feeding was suggested in
949/1582 (60%) infants with one or more of the gastroin-
testinal symptoms we recorded, and in 203/1297 (15.5%)
of the infants who did not suffer from any gastrointestinal
problems (in 192 out of these 203 due to the presence of
Fig. 1. Frequency (number and percentage of the total number of cases of
hospitalisation) of regurgitation, colic, constipation, failure to thrive, vom-
iting and diarrhoea as the cause of hospitalisation in the 93 infants who
were hospitalised for gastrointestinal symptoms during the first 6 months
after birth. More than one symptom in the same subject may have led to
hospitalisation.
435
Constipation Failure to thrive Vomiting Diarrhoea
(N = 507) (N = 439) (N = 174) (N = 117)
N.S. N.S. N.S. N.S.
N.S. P < 0.001 P < 0.05 N.S.
N.S. N.S. N.S. P < 0.002
N.S. N.S. N.S. N.S.
N.S. N.S. N.S. N.S.
P < 0.007a N.S. N.S. N.S.
dermatological or respiratory symptoms, in 11 patients for
reasons not recorded). As regards each symptom, a change
in feeding was suggested in 414/664 (62.3%) infants with re-
gurgitation (P < 0.0001 versus all the other infants included
in the study), 303/589 (51.4%) infants with colic (P < 0.0001
versus all the other infants included in the study), 253/507
(49.9%) infants with constipation (P < 0.0001 versus all the
other infants included in the study), 278/439 (63.4%) infants
with failure to thrive (P < 0.0001 versus all the other infants
included in the study), 113/174 (65%) infants with vomiting
(P < 0.0001 versus all the other infants included in the study),
and 76/117 (64.6%) infants with diarrhoea (P < 0.0001 ver-
sus all the other infants in the study). In none of the infants
who were breast-fed at the onset of their symptoms a change
in feeding habit was suggested. A feeding change was sug-
gested in mixed- or bottle-fed infants who were receiving
various cow-milk-derived, adapted formulas.
5. Discussion
The presence of gastrointestinal symptoms is a frequent
problem in paediatric patients and often determines numer-
ous visits to the paediatrician, changes in feeding, parental
anxiety and loss of parents’ working days. Despite these rel-
evant sanitary and social aspects, very little is known about
the frequency of the ‘minor’ gastrointestinal disturbances in
infancy and the possible determining factors associated with
their onset. In fact, to our knowledge, no epidemiological
studies have evaluated these aspects in the general popula-
tion.
Consequently, we performed the present prospective
population-based study to evaluate the frequency, from birth
to 6 months, of the six disturbances which we considered
the most common in infants: regurgitation, vomiting, diar-
rhoea, constipation, colic and failure to thrive. To do so, we
requested the collaboration of 150 paediatricians distributed
throughout Italy, who monitored approximately 3000 healthy
infants. A printed clinical chart allowed us to obtain detailed
information about the onset of gastrointestinal disturbances
and the presence of possible associated causal factors.
Our results showed that the ‘minor’ gastrointestinal dis-
turbances are frequent in infants: in fact, we observed a symp-
436 G. Iacono et al. / Digestive and Liver Disease 37 (2005) 432–438
tom in over half of the infants studied (1582/2879; 54.9%).
Regurgitation was the most common disturbance, as it was
present in 664/2879 infants (23.1%). This result was not at all
surprising, as regurgitation can be considered a physiological
phenomenon in infants in the first year of life [3] and it has
been reported that 50% of all infants 0–3 months regurgitate
at least once a day [4]. It is due to gastro-oesophageal reflux
(GER), whose frequency in children has been estimated be-
tween 1% and 22% [5,6], but most infants with regurgitation
and GER are not brought to medical attention [7]. Vomit-
ing, another symptom which could indicate GER, was found
in our study in a much lower percentage of infants than re-
gurgitation: 6%. However, it must be remembered that this
symptom can be due to a number of different pathological
conditions, such as central nervous system diseases, pyloric
stenosis, etc., and it cannot automatically be associated with
GER [8,9].
The second most frequent symptom we recorded was in-
fantile colic. Frequency in our study was 20.5%, thus in the
range (16–48%) of the incidence estimated in other studies
[2,10]. It is known that the pathogenesis of infantile colic is
considered to be either based on psycho-social factors and
disturbances in the mother-child relationship [11], or linked
to cow’s milk protein intolerance [12,13], or to GER [14].
These latter two diseases can be treated with a dietary ap-
proach.
Constipation was the third most frequent symptom we
observed, as it was present in 17.6% of the infants. Our defi-
nition of constipation (‘one bowel movement every 3 days or
more’) is lower than the third percentile of bowel movement
frequency in healthy age-matched infants [1]. To our knowl-
edge, there are no other studies reporting the frequency of
constipation in neonates or infants younger than 6 months.
It is noteworthy that in the present study constipation was
linked to a lower frequency of breast-feeding; this result is
in agreement with previous evidence that breast-fed healthy
infants pass stools almost 50% more often than formula-fed
infants [1].
In general, low birth weight was the factor most frequently
associated with the presence of gastrointestinal symptoms.
This is in agreement with previous studies which reported
impaired digestive function not only in pre-term infants but
also in full-term infants small for their gestational age [15].
Despite the very high frequency of gastrointestinal symp-
toms, only 3.2% of the infants (93/2879) were hospitalised for
one or more of these symptoms. Hospitalisation was probably
determined by the presence of more than one single symptom;
in fact 58/93 hospitalised infants had two or more gastroen-
terological symptoms as has been reported in the cases of
vomiting and constipation [16].
Finally, it is interesting to recall the relationship between
the type of feeding given to the studied infants and their gas-
troenterological disturbances. In general, our study popula-
tion was characterised by a high frequency of breast-feeding
(81%) and a correspondingly low frequency of bottle-feeding
(11%), at the beginning of the study. In contrast with the
more obvious expectations, we did not find a higher fre-
quency of gastrointestinal symptoms in bottle-fed than in
breast-fed infants. The only influence of the type of feeding
was recorded in constipated infants with a lower frequency of
breast-feeding than infants without constipation. As several
studies have underlined the great and numerous advantages
of breast-feeding [17,18], the observation of a low relation
between bottle-feeding and gastrointestinal symptoms in the
first 6 months after birth must not determine any change in
the paediatric policy of encouraging the diffusion of breast-
feeding. Furthermore, it must be considered that during the
study period many infants changed their feeding, suspending
breast-feeding and beginning mixed- or exclusively bottle-
feeding.
Another aspect to comment on is the influence that the on-
set of a gastrointestinal symptom had on feeding. In patients
with one or more gastrointestinal symptoms a change was ob-
served in about 60%, whereas it was recorded in only 15.5%
of the infants without gastrointestinal troubles (in these cases
mainly due to the appearance of respiratory or dermatological
symptoms). This result seems to indicate that gastrointestinal
symptoms are the main reason for change feeding in infants.
Although we have no data as to the type of new milk formula
prescribed at the onset of the gastrointestinal symptoms, it
appears obvious to hypothesise that a number of ‘thickened’,
lactose-free, partially hydrolysed, and/or other ‘curing’ for-
mulas were prescribed. The cost of these ‘dietary’ formulas
is generally much higher than that of the common adapted
formulas; consequently the economic impact of the ‘minor’
gastrointestinal troubles of the infants merits a more detailed
investigation and the real usefulness of the change in milk for-
mula should be evaluated in future studies, although there is
evidence that both regurgitation, GER and colic can improve
with dietary treatment [4,6,19,20].
In conclusion, we found that gastrointestinal symptoms
are very common in infants during the first 6 months after
birth; these symptoms caused hospitalisation in a small
percentage of cases (3%), but determined the prescription of
a ‘dietary’ milk formula in about 60% of cases.
Conflict of interest statement
None declared.
Acknowledgement
We would like to thank Mrs. Carole Greenall for her pre-
cious revision of the English.
Appendix A. Paediatric Study Group on
Gastrointestinal Symptoms in Infancy
Paediatricians involved in the study to record the presence
of gastro-intestinal symptoms in the first 20 infants registered
with them during the study period:
 G. Iacono et al. / Digestive and Liver Disease 37 (2005) 432–438
Di Palma Salvatore, Bartolucci Giuliana, Palumbo Ma-
rina, Collacciani Giuseppe, Cappellini Cristina, Santilli An-
tonella, Righetti Maria, Santirocco Maria Rita, Petitta Marco,
Massimino Stefania, Ferraro Gabriella, Crua Giorgio, Zicari
Francesco, Mietta Adriano, Baldassar Ferraro AnnaMaria,
Martino Filomena, Imperiale Claudio, Barrile Luciano, Sanni
Letteria, Gatto Silvana, D’urso Giovanna, Fiamingo Mario,
Gattarello Annunziata, Martelli Dafne, Cinconze Salvatore,
Moroni Emiliano, Caronariti Valeria, Bravetti Emanuela,
Martines Maristella, Pellegrini Lucia, Serra Margherita, De
Felicis Arcangeli Carla, Cesarini A.Rita, Paolini Fabrizia,
Candio Francesco, Orrù Gennaro, Bellaveglia M.Luisa, Gra-
menzi Rita, Bianchini Fabrizio, Bonsi Simonetta, Gozzo
Matilda, Franchini Maddalena, Miglioranzi Paola, Prev-
idi Mauro, Melotti Giancarlo, Monicelli Ugo, Martone
Gabriella, Reali Laura, Manetta Fiorella, Ferrazzoli Maria
Lucia, Diamanti Isabella, Falletta Salvatore, La Cava Gio-
vanna, Paoletti Silvia, Andreini Carla, Bianchera Raffaella,
Locatelli M. Elisa, Mannori Carlo, Sabatini Walter, Pasquini
Anna, Pasquini Fulvio, Grossi Cristina, Belsito Luisa, Rana
Pierangela, Scadavecchia Laura, Balducci Ottavio, Pecca-
risi Lucia, Bonvino Angelica, De Laurentis Lelio, Zarella
Mariolina, Farinelli Claudio, Pasquantonio Antonella, An-
togiovanni Assunta, Antogiovanni Luigi, Favi Valeria, De
Vino Annette, Totaro Lucia, Becattini Laura, Casaregola
Matilde, Barone Patrizia, Dau Giovanna, Argellati San-
dra, Testori Franco, Maggiani Giuliano, Antonini Emanuela,
Bawa Paola, Pandolfi Maria Eva, Borsellino Giuseppe, Mog-
naschi Claudia, De Martino Flavia, Perfetti Miriam, Lon-
goni Rosa Maria, Marchione Laura, Invernizzi Lorella,
Salvioni Francesca, Mariani Daniela, Gelpi Bruna, Carch-
esio Isidora, De Angelis Monica, Thiebat Elena, Romeo
Lucia, Bollani Tiziana, Colombo Mania, Florioli Alessan-
dro, De Poli Daniela, Bonori Massimo, Barbera Caterina,
Denis Franca, Calore AnnaMaria, Criconia Carla, Giaretta
Letizia, Menegus Elena, Passuello Giovanna, Turio Chiara,
Ranieri Luigi, Grotteria Salvatore, Lentidoro Irene, Pelaggi
Paola, Gullo Paola, Marino Filippo, Giancotti Laura, Li-
cata Caruso Donatella, Esposito Andreina, Chianese Anna
Maria, Masini Luigi, Greco Palmira, Lamanna Sergio, Maida
Walter, Iovine Alfredo, Vitiello Giuseppe, Mariani Laura,
Botto Anna, Cuocco Anna, Rampini Luigina, Pioggio Cinzia,
Bellati Rosanna, Fontana Carla, Ettore Silvia, Gatto Ful-
via, Caneva Egidio, Bianchi Gianpiero, Calcante Sara, Per-
rone Maria Sara, Saggese Teresa, Fallarino Stefania, Boffelli
Elena, Aramini Lucio, Cornalba Ludovico, D’amato Vin-
cenza, La Macchia Nicola, Mineo Santa, Paternostro Daniela,
Piricò Laura,Scillieri Maria Adriana, Costagliola Rosalba,
Spataro Maria, Frezzetti Andrea, Fattore Stanislao, Coronella
Angelo, Brunese Francesco Paolo, Minichino Anna Maria,
De Vita Sergio, Mandia Francesco, Falcone Anna Maria,
Mastrominico Augusto, Cavazzuti Donatella, Boschini Ce-
sare, Baroni Isabella, Mazzini Franco, Ponti Roberto, Luc-
chi Elide, Faedi Clara, Trebbi Miro, Mele Roberto, Cera
Melania, Rosas Paolo, Pala Antonio, Urru Luciano, Piras
Stella, Zichera Tiziana, Cartone Franca, Centamore Maria,
437
Ferro Sebastiana, Duminuco Calogera, Caltabiano Loredana,
Scaringi Carmelo, Spedace Antonella and Francario
Elisabetta.
Clinical monitors who visited the paediatricians involved
in the study to help them compile the clinical charts and to
verify that the data were recorded correctly according to the
study protocol definitions:
Cinque Massimo, Coppo Elena, De Leo Silvana, Del Giu-
dice, Di Bitetto Rosa Rina, Ferraro Luigi, Ganzarolli Stefania,
Gibaldi Giovanni, Landini Luca, Losurdo Luigi, Maraglino
Vita Maria, Merusi Ilaria, Moscatelli Daniela, Otelli Valeria,
Panisi Cristina, Panizzolo Cristina, Pensabene Lucia, Porzio
Salvatore, Ravera Brunella, Ricci Antonio, Russo Delia, Sta-
bile Donatella, Viola Laura, Putzu Sandro and Montes Se-
bastiana.
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