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Is Intermittent Phototherapy equally effective and has less side effects as compared with continuous phototherapy when used in treatment of neonatal jaundice in babies less than 1500 g birth weight - A Randomized Trial (CyPhoR TRIAL)

Cycled Phototherapy Dose Finding Study for Very Low Birth Weight Neonates-A Randomized Controlled Trial (CyPhoR TRIAL) - CyPhoR trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036233
Enrollment
360
Registered
2021-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P589- Neonatal jaundice due to excessivehemolysis, unspecified

Interventions

Intervention1: Group B: LED phototherapy with flux 30 microwatts per centimeter square for 1 hour every 3 hours i.e. Total 8 hrs. per day : babies included in study will be divided into 3 groups int

Sponsors

Goa Medical College And Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. inborn/outborn infants 2. Infants weighing 3. Infants who have not received any phototherapy prior

Exclusion criteria

Exclusion criteria: 1. Previous phototherapy > 6hours before enrolment 2. TSB reported as >6.0 mg/dL before 12 hours age 3. Major congenital anomaly

Design outcomes

Primary

MeasureTime frame
Primary outcomes: 1)Peak TSB 2)maximum duration of phototherapy exposure 3)Rate of reduction of TSB 4)Number of Exchange Transfusion 5)incidence of PDA, IVH, ROP, BPD 6)Number of Deaths Secondary Outcomes: 1)Incidence of Neurodevelopmental Delay at follow up @ (1,3,6,9 months) 2)Hearing impairment at follow up 3)Vision Impairment at follow up Timepoint: at recruitment at discharge at 3,6 9,12 months of age

Secondary

MeasureTime frame
1)Incidence of Neurodevelopmental Delay at follow up @ (1,3,6,9 months) 2)Hearing impairment at follow up 3)Vision Impairment at follow up Timepoint: at discharge and at 1,3,6,9 12 months of age

Countries

India

Contacts

Public ContactDr Dipti Parab

Goa Medical College And Hospital Bambolim

diptiparabhere@gmail.com9765796157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026