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 of 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 (Total 338 neonates) Initial assessment for Neonatal with sepsis – 248 enrollment (term, age < 14 Neonatal with Rh incompatibilities – 35 days, jaundice) total 398 Neonatal with conjugated Excluded hyperbilirubinemia -25 Neonatal with congenital anomalies - 30 Eligible neonates for studies N=60 Randomized Group A (n 1 = 30) Group B (n 2 = 30) Received fenofibrate along with Received phototherapy phototherapy Followed up Followed up

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 of oral 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) P Group A(n 1 =30) Group B(n 2 =30) Mean ± SD Mean ± SD value Birth weight(gm) (Mean ± SD) 2880.00 ± 304.44 2906.66 ± 323.69 0.744 39.00 ± 1.4 39.00 ± 1.6 Gestational age (wks) (Mean ± SD) 1.00 5.56 ± 3.30 5.86 ± 3.00 Postnatal age(days): Mean ± SD) 0.717 13.6 ± 0.89 13.70 ± 0.99 Hb level (gm/dl) 0.731 57.2 ± 0.84 59.7 ± 0.72 Absolute Reticulocyte count 29.83 ± 5.55 27.98 ± 4.43 SGPT(U/L) 0.250

Table 4.3: Comparison of plasma bilirubin values during treatment between fenofibrate group (group A) and control (group B ) (N=60) Serum Group Group B( n 2 =30) P value bilirubin A(n 1 =30) Mean ± SD Mean ± SD level(mg/dl) 16.86 ± 0.89 17.31 ± 1.19 On 0.107 admission 14.83 ± 0.95 15.73 ± 1.32 At 24 hours 0.004 12.85 ± 1.06 14.20 ± 1.24 At 48 hours 0.001

Table 4.4: Rate of fall of serum bilirubin after 24 and 48 hours (N=60) Change of serum Group Group P bilirubin level A(n 1 =30) B(n 2 =30) value Mean ± SD Mean ± SD 11.89 ± 5.55 9.07 ± 5.11 24 hours 0.045 23.75 ± 5.47 17.87 ± 5.46 48 hours 0.001

Table 4.5: Distribution of the study population by duration of phototherapy (N=60) Group A Group B P value (n 1 =30) (n 2 =30) Mean ± SD Mean ± SD 51.20 ± 8.29 70.40 ± 6.08 Duration of 0.001 phototherapy (hrs)

Table 4.6: Distribution of the intervention group (group A) by SGPT before and after giving fenofibrate ( n 1 =30) Before After P value fenofibrate fenofibrate Mean ± SD Mean ± SD 0.163 29.83 ± 5.55 28.20 ± 5.33 SGPT(U/L)

Conclusion The use of single dose of fenofibrate with phototherapy decreases the level of serum bilirubin more rapidly and shortened the time needed for phototherapy. Fenofibrate is well tolerated and is not associated with any side effect.