Title EFFECT OF SINGLE DOSE FENOFIBRATE AS AN ADJUNCT TO - - PowerPoint PPT Presentation

Title

EFFECT OF SINGLE DOSE FENOFIBRATE AS AN ADJUNCT TO PHOTOTHERAPY ON UNCOMPLICATED NEONATAL HYPERBILIRUBINEMIA

• Dr. Tithi Islam

FCPS,MD Junior Consultant Manikgang Sadar Hospital

Introduction

• Early recognition and adequate management of

neonatal hyperbilirubinemia are important because some hyperbilirubinemia may cause encephalopathy. Timely and appropriate treatments with phototherapy and/or exchange transfusion are effective. Some pharmacological agents like Fenofibrate along with phototherapy decreases the time needed for phototherapy,

.

Cont…

lessen the duration

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hospital stay and morbidity associated with nosocomial infection.

• Fenofibrate is a fibric acid derivatives which

stimulates hepatic peroxisome proliferation and bilirubin glucuronidation. Thus it induce bilirubin conjugation more rapidly and decreases the time needed for phototherapy.

Hypothesis

Fenofibrate as an adjunct with phototherapy reduces serum billirubin more effectively than phototherapy alone in neonates with uncomplicated hyperbilirubinemia.

Objective

To determine the efficacy of single dose fenofibrate in adjunct with phototherapy in the treatment of uncomplicated neonatal hyperbillirubinemia.

Materials & Methods

• Type of Study: Randomized controlled clinical

trial

• Place of study: Neonatal ward, Dhaka shishu

Hospital, Dhaka

• Study period: One year (April 2016 to March

2017).

• Sample Size: 60

Inclusion criteria

• Unconjugated hyperbilirubinemia needed

phototherapy

• Term (with gestational age of 37completed

weeks-41 completed weeks)

• Age 0- 14 days
• Sex: Both sexes
• Body weight :2500 to 3999 gm

Exclusion criteria

• Neonate with conjugated

hyperbilirubinemia (>2mg/dl or >20% of total serum bilirubin)

• Neonate with Rh incompatibility
• Neonate very sick at admission
• Neonates with congenital anomalies

Study procedure

• Flow chart of study population

Initial assessment for enrollment (term, age < 14 days, jaundice) total 398 (Total 338 neonates) Neonatal with sepsis – 248 Neonatal with Rh incompatibilities – 35 Neonatal with conjugated hyperbilirubinemia -25 Neonatal with congenital anomalies - 30 Eligible neonates for studies N=60 Group A (n1 = 30) Received fenofibrate along with phototherapy Followed up Group B (n2 = 30) Received phototherapy Followed up

Excluded Randomized

Cont…

• Tablet fenofibrate 160mg dissolved in 10ml

distilled water to get concentration 16 mg fenofibrate in 1ml. Group A or interventional group (n=30) received single dose

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fenofibrate (10mg/kg) along with phototherapy at the beginning.

Cont..

• Blood sample was collected every 24 hour for

total and indirect bilirubin till bilirubin level fall below phototherapy range.

• SGPT was done before and after 24 hours of

giving fenofibrate.

Results

Table 4.1 Base line data of study population (N=60)

Group A(n1=30) Mean ±SD Group B(n2=30) Mean± SD

P value

Birth weight(gm) (Mean ±SD) 2880.00 ±304.44 2906.66± 323.69 0.744 Gestational age(wks) (Mean± SD) 39.00± 1.4 39.00 ± 1.6 1.00 Postnatal age(days): Mean± SD) 5.56 ± 3.30 5.86± 3.00 0.717

Hb level (gm/dl)

13.6± 0.89 13.70 ± 0.99 0.731

Absolute Reticulocyte count

57.2 ± 0.84 59.7± 0.72

SGPT(U/L)

29.83± 5.55 27.98± 4.43 0.250

Table 4.3: Comparison of plasma bilirubin values during treatment between fenofibrate group (group A) and control (group B) (N=60)

Serum bilirubin level(mg/dl) Group A(n1=30) Group B( n2=30) P value Mean± SD Mean ± SD On admission 16.86 ± 0.89 17.31± 1.19 0.107 At 24 hours 14.83 ± 0.95 15.73 ±1.32 0.004 At 48 hours 12.85 ± 1.06 14.20 ± 1.24 0.001

Table 4.4: Rate of fall of serum bilirubin after 24 and 48 hours (N=60)

Change of serum bilirubin level Group A(n1=30) Group B(n2=30) P value Mean± SD Mean± SD 24 hours 11.89 ± 5.55 9.07 ± 5.11 0.045 48 hours 23.75 ± 5.47 17.87± 5.46 0.001

Table 4.5: Distribution of the study population by duration of phototherapy (N=60)

Group A (n1=30) Group B (n2=30) P value Mean±SD Mean±SD Duration of phototherapy (hrs) 51.20±8.29 70.40±6.08 0.001

Table 4.6: Distribution of the intervention group (group A) by SGPT before and after giving fenofibrate ( n1=30)

Before fenofibrate After fenofibrate P value Mean ±SD Mean ± SD 0.163 SGPT(U/L) 29.83 ± 5.55 28.20± 5.33

Conclusion

The use of single dose of fenofibrate with phototherapy decreases the level

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serum bilirubin more rapidly and shortened the time needed for phototherapy. Fenofibrate is well tolerated and is not associated with any side effect.