A Randomised controlled trial comparing the duration of phototherapyfollowing NICE(UK) and AAP guidelines in neonatal hyperbilirubinemia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- The primary outcome variable is duration of phototherapy.
Study Overview
Brief Summary
Introuction:Nearly 60% of newborns become clinically jaundiced sometime during the first week of life. 1 In neonatal hyperbilirubinemia which is predominantly unconjugated.Excess production of bilirubin along with hepatic immaturity plays a key role.If uncontrolled this hyperbilirubinemia can lead to kernicterus with its devastating neurodevelopmental outcome.Effective phototherapy reduces the chance of kernicterus drasticallybut in a resource constrained country like India recipients always outnumber resources, thats why a phototherapy protocol with a shorter duration of phtotherapy is of greater importance .Of the guidelines practiced worldwide, AAP 2004 and NICE 2010 neonatal hyperbilirubinemia guidelines are the two most accepted ones for treating jaundiced newborn.Both have set their own starting and end points of treatment, but it is not known whether using one guideline over the other will lead to a longer duration of phototherapy of more incidences of treatment failure or whether more number of babies get treatment unnecessarily by any of these guidelines.
Aim:To evaluate whether the AAP guideline is able to treat babies with hyperbilirubinemia with phototherapy for a shorter duration in comparison to the NICE guideline.
DESIGN: This is a open labeled, single centre, prospective, randomized controlled trial .128 consecutively born babies with neonatal jaundice admitted in NICU of SSKM and IPGMER hospital, Kolkata during the study period will be included in the study after their parents have given informed consent in writing.Babies with major congenital malformtion and hemolytic jaundice will be be excluded from the studyHere after all such babies will be randomized into 2 groups. The control group comprising of 64 babies will continue to receive phototherapy by AAP guideline whereas the other group comprising of 64 babies will receive phototherapy in accordance to NICE 2010 guideline.Both the groups will receive phototherapy by LED phottherapy unit.
Babies will be followed up for rebound hyperbilirunemia ,hearing impairment and neurological examination when they reach gestaional age of 40 weeks
Direct coomb test, reticulocyte count , G-6 PD level will be estimated to ascertain treatment failure.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Day(s) to 7.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All babies requiring phototherapy for neonatal hyperbilirubinemia between 35-42 weeks of gestational age will be included in the study.
Exclusion Criteria
- •a.Any baby having major congenital malformation b.Babies with haemolytic jaundice.
Outcomes
Primary Outcomes
The primary outcome variable is duration of phototherapy.
Time Frame: 6hrs,12hrs,24hrs,48hrs.
Secondary Outcomes
- The secondary outcome variables are treatment failure and rebound(hyperbilirubinemia.)