Skip to content

To assess the ease of use by caretakers regarding wearable blue light therapy for newborn jaundice upon routine blue light therapy

To evaluate the natural care aspects of using the phototherapy romper in term neonates, upon conventional therapy for hyperbilirubinemia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/074315
Enrollment
10
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Intervention1: phototherapy romper: It is a wearable LED device which uses specially designed clothing with embedded blue light LEDs. It is not for medical treatment but for enhancing the natural care

Sponsors

Dr V Shanmugapriya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Newborns at or above 35 weeks gestation with pre-discharge TSB level placing the newborn in high-intermediate and low-intermediate risk zone. 2 Parent or legal guardian who provide informed consent for their baby participation in the study

Exclusion criteria

Exclusion criteria: 1 Newborn below 35 weeks gestation 2 Newborn with contraindication to phototherapy 3 Newborns with co-morbidities other than hyperbilirubinemia 4 Parents or legal Guardian who do not provide consent for their baby participation in the study

Design outcomes

Primary

MeasureTime frame
The endpoint of the study is the completion of the usability assessment and filling of the questionnaires by the neonatologists, nurses and the parents/legal guardians. Timepoint: 2-5 days

Secondary

MeasureTime frame
1 Duration of phototherapy required to achieve clinically acceptable bilirubin levels for stopping phototherapy. 2 Adherence to using the phototherapy romper during kangaroo mother care and feeding periods. Timepoint: 2-5 days

Countries

India

Contacts

Public ContactPoonguzhali

Hindusthan hospitals

bommupsk@gmail.com7708957920

Outcome results

None listed

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