Defecation characteristics of the preterm and term neonate during the first years of life

No well designed studies exist describing normal stool characteristics
(defecation frequency, consistency and colour of stools) of premature,
low-birth weight and term born infants. Furthermore, the duration of
meconium stools before the appearance of normal stools is unknown.
Although no normal data on stool characteristics exist some studies
report that between 60-70% of the older children with constipation
already had symptoms ofI constipation n the first months of life. To
our opinion it is therefore of major importance to first describe the
normal frequency of stools, consistency, amount and colour of the
stools among preterm, dysmature and full term new born and subsequently
extrapolate these data to make a definition for constipation in the
neonate.

What is the normal stool frequency among premature and full term
neonates?
What is the normal colour of stools of the neonate?
What is the normal consistency and amount of stools?
What is the normal colonic transit time of premature and full term born
neonates?
Is it possible to define criteria for constipation of the neonate
period based on the normal data we collect of the infants described
above?

All newborn neonates who are admitted on the Units II and III of the
AMC will be included if they meet the inclusion criteria (Premature and
low birth weight neonates, gestational age 25-37 weeks and full term
neonates born in our Academic Medical Center, gestational age 38-42
weeks).
Defecation frequency of all new born neonates will be recorded daily in
standardized bowel diary from the first day of life until the first 4
weeks of life. Symptoms such as distended abdomen, vomiting, volume and
type of feeding, first and last day of meconium stools will also be
registered. Furthermore, stools will be visualised by taking pictures
with a digital camera. Two doctors will independently evaluate the
stool pictures. The photos will hopefully be used as standardized stool
picture scoring system to evaluate the defecation pattern of neonates.

Furthermore, the colonic transit time will be evaluated by the use of
Carmine red. Carmine red is an inert non-absorbed dye, which is bright
red in colour and readily identifiable in neonatal stools. Side
effects of Carmine red are not described in neonates. Three weeks and 6
weeks after birth neonates will receive 250 mg of Carmine red
administered via a nasogastric tube. Only neonates who receive a
minimum of 4 ml/ kg enteral feeding per day will get the carmine red.
Colonic transit time is the time measured between administration and
the first time that the dye is seen in the diapers of the neonate.

During the study period of three months, the newborn infants will be included
into the study. The sample size will depend on the parents willing to
participate into the study. We expect to include 60 preamture and 60 full term
newborns.

There are no risks on participating in this study.

Parents will be asked to record the defecation pattern of their child in a
standardized stool diary for seven subsequent days. This will be done on t = 2,
6, 9,12, 24 and 36 months.
The parents of healthy full term infants will be asked to administer Carmine
red twice, on week 3 and week 6 after birth. The premature neonate will receive
Carmine red via the nasogastric tube.