Efficacy of probiotics in reducing the severity and duration of neonatal hyperbilirubinemia

160 neonates, meeting the
selection criteria, admitted in Neonatal Intensive Care of the Pediatrics department at Pakistan Air Force
Hospital, Islamabad, will be enrolled in the study, after obtaining informed written consent from
parents/guardians. Demographic details like registration number, age,
gender, birth weight, gestational age at delivery, type of feeding, and serum total bilirubin level
at baseline will be noted. The neonates will be divided randomly into two groups by allocating
even numbers to Group A and odd numbers to Group B participants. In group A, neonates will
be given phototherapy along with oral probiotics (Enterogermina containing Bacillus Clausii –

2.5ml twice daily for 2 consecutive days) and group B will be given phototherapy by
consecutive non-probability sampling. The baseline STB level will be noted. Then neonates will
be followed-up for 12, 24, and 48 hours of treatment in the NICU. On each follow-up, a 2ml
blood sample will be taken in a red top serum vial and sent to the laboratory for assessment of
bilirubin level. STB will be assessed at 12, 24, and 48 hours of treatment and a reduction in
mean STB level at 12, 24, and 48 hours of treatment will be calculated from baseline (as per the
operational definition). Moreover, the effect of probiotics on the major clinical course including
the duration of phototherapy, duration of hospitalization, and the need for exchange transfusion
will be assessed. All the data will be collected by using the proforma. To reduce
selection bias within the study and maintain the quality of the data, the researcher along with
paramedical staff will collect and maintain all data.

2024-08-01

2024-12-31

All the collected data will be recorded and analyzed in SPSS Software (version 23). Numerical
variables like age, weight, gestational age, bilirubin level (before, and after 12, 24, and 48 hours
of treatment), duration of phototherapy, hospital stay and reduction in STB will be calculated as
mean ± standard deviation. Frequency and percentage will be calculated for qualitative variables
like gender and feeding pattern. For comparison between the groups, the independent samples t-
test will be applied for quantitative variables. The paired t-test will be used to compare the mean
reduction in bilirubin level in both groups pre and post-intervention and a p-value of ≤0.05 will
be taken as significant. The effect modifiers such as gestational age at birth, gender, and mode of
feeding will be stratified by using post stratified independent sample t-test.

Randomized control trial

Consecutive non-probability sampling

no cluster randomization was done

No

160 neonates

same as above

80 in each group i.e. one with phototherapy alone and the other with phototherapy along with probiotics

90%