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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/04/005705 |
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Date of registration:
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20-04-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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When to stop phototherapy in neonatal jaundice?
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Scientific title:
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When to stop phototherapy in neonatal hyperbilirubinemia? - A Randomized Control Trial |
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Date of first enrolment:
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02-02-2015 |
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Target sample size:
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270 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11207 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Srinivas Murki
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Address:
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2nd Floor,
Department of Neonatology,
Hyderguda,
Telangana,
Hyderabad
500029
Hyderabad, ANDHRA PRADESH
India |
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Telephone:
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Email:
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srinivasmurki2001@gmail.com |
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Affiliation:
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Fernandez Hospital |
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Name:
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Dr Tejopratap Oleti
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Address:
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2nd Floor,
Department of Neonatology,
Hyderguda,
Telangana,
Hyderabad
500029
Hyderabad, ANDHRA PRADESH
India |
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Telephone:
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Email:
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srinivasmurki2001@gmail.com |
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Affiliation:
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Fernandez Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Neonates >= 35 wks of gestation
• Birth weight more than 1800grams
• Received phototherapy as per AAP phototherapy charts for minimum duration of 24 hours.
Exclusion criteria: Neonates with major congenital anomalies or underwent Exchange Transfusion
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Neonates â?¥ 35 wks of gestation with birth weight more than 1800grams and received phototherapy as per American Aacademy of Pediatrics phototherapy charts for minimum duration of 24 hours.
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Intervention(s)
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Intervention1: Group A: Phototherapy will be stopped immediately. TSB will be monitored after 12 hours. If the value of TSB is less than 12mg/dl, infant will be discharged home.
Control Intervention1: Group B: Phptotherapy (PT) will be continued till the TSB is less than 12mg/dl on two consecutive occasions at 12 hours interval. On stopping the PT, infant will be monitored after 12 hours with TSB. If the value of TSB is less than 12mg/dl infant will be discharged home.
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Primary Outcome(s)
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Rate of occurrence of hyperbilirubinemia as measured by the number of episodes of rebound hyperbilirubinemia/ total number of neonates enrolled. Rebound hyperbilirubinemia defined as TSB more than AAP age specific cut-off after stopping phototherapy or a rise of bilirubin greater than 0.5mg/hour.Timepoint: Will be followed till 48 hrs after stopping phototherapy
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Secondary Outcome(s)
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Risk factors for developing rebound hyperbilirubinemiaTimepoint: Will be followed till 48 hrs after stopping phototherapy
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Duration of rebound phototherapy as measured in hoursTimepoint: Till discharge
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Source(s) of Monetary Support
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Fernandez Hospital, Hyderabad
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Ethics review
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Status: Approved
Approval date: 28/01/2015
Contact:
Institute Ethics Committe
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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