CTRI/2018/02/011740Not yet recruitingNot Applicable
A comparison of two targets of serum bilirubin concentration for phototherapy discontinuation in neonatal jaundice.
Veda Senthil Velan Ganesan1 site in 1 country240 target enrollmentStarted: December 2, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Number of babies who require re-initiation of phototherapy.
Study Overview
Brief Summary
This study is a randomized, open labelled, parallel group, single centre study comparing the occurance of significant rebound jaundice when phototherapy was stopped in two targets below the treatment threshold in babies with neonatal jaundice. Secondary outcomes will be compared are total duration of phototherapy and total duration of hospital stay in two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Day(s) to 7.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Babies with gestational age ≥35 weeks, 2)Babies with birth weight >1800 grams, 3)Babies requiring phototherapy for the first time, 4)Babies with onset of jaundice ≤7 days.
Exclusion Criteria
- •Babies planned for immediate exchange transfusion at the time of admission.
Outcomes
Primary Outcomes
Number of babies who require re-initiation of phototherapy.
Time Frame: 24 hours after stopping phototherapy
Secondary Outcomes
- Total duration of phototherapy including treatment after rebound hyperbilirubinemia and total duration of hospital stay.(Less than 7 days)
Investigators
Study Sites (1)
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