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Comparison between two eye covering devices used during phototherapy

Neo i Care (control) vs Giggles (study) eye covering devices used during phototherapy in full term neonates.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031780
Enrollment
60
Registered
2021-03-08
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: K769- Liver disease, unspecified

Interventions

Intervention1: Giggles eye covering: Jaundiced neonates fulfilling the criteria for phototherapy will be allocated to either Giggles or NeoiCare eye covering Control Intervention1: NeoiCare eye coveri

Sponsors

Dr Uday Devaskar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates born at >36 weeks of gestation at birth needing PT.

Exclusion criteria

Exclusion criteria: Neonates with â?? 1) Skin disease like ichthyosis, existing conjunctivitis, suspected nasolacrimal duct obstruction, 2) Abnormal neurologically examination during the study period 3) Clinically suspected or proven sepsis, 4) Moderate to severe respiratory distress, 5) Circulatory shock and 6) Parental refusal.

Design outcomes

Primary

MeasureTime frame
Compare the number of spontaneous dislodgements of Giggles versus Neo i Care needing reapplication. Timepoint: 5 months

Secondary

MeasureTime frame
1) Compare the incidence of eye discharge. 2) Assess the level of babyâ??s discomfort or irritability. 3) Assess the number of apnea episodes. 4) Compare the incidence of conjunctival redness, periorbital skin rash. 5) Assess user friendliness based on the survey. 6) Assess the degree of visual esthetics.Timepoint: 5 months

Countries

India

Contacts

Public ContactDr Uday Devaskar

Deenanath Mangeshkar Hospital, Pune

udevaskar@mednet.ucla.edu

Outcome results

None listed

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