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Bottom LED phototherapy versus conventional top LED phototherapy for neonatal jaundice.

Effectiveness, safety and comfort of new innovative bottom LED phototherapy with air mattress versus conventional top LED phototherapy for neonatal jaundice in neonates of more than 35 weeks gestation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040737
Enrollment
120
Registered
2022-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Bottom surface LED phototherapy with air mattress: Babies will be provided phototherapy from bottom by placing the baby over the air mattress which is placed over the phototherapy unit.

Sponsors

Premkumar Segaran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates more than 35 weeks identified to have jaundice to the extent of requiring phototherapy according to AAP (2004) chart.

Exclusion criteria

Exclusion criteria: 1.Neonates with S.Bilirubin more than 20 mg/dl or rate of rise of bilirubin more than 0.5 mg/dl per hour. 2. Major congenital anomalies, 3.Babies on any respiratory support or requiring IV line insertion for any reason. 4.Sepsis and dehydration more than 15 % 5.IUGR and SGA babies. 6.Babies requiring resuscitation at birth or instrumental deliveries. 7.Babies of mothers who received AN steroid ( even 1 dose). 8. Parents who denied consent for to be included in the study.

Design outcomes

Primary

MeasureTime frame
To assess the comfortness of the new bottom LED phototherapy unit with air mattress by measuring serum cortisol level when compared to the top LED conventional phototherapyTimepoint: S.Cortisol will be measured before starting, after every 24 hours of phototherapy, and 24 hrs after stopping phototherapy.

Secondary

MeasureTime frame
Bilirubin reduction in mg/dl/hrTimepoint: S.bilirubin will be measured before starting phototherapy, after every 24 hrs of phototherapy and 24 hrs after stopping phototherapy.;Parents and Nurses experience in using the devicesTimepoint: LIKERTs scale will be scored after stopping phototherapy.;To assess the effect on Neonatal Behavior by COMFORTneo scaleTimepoint: Comfortneo Scale will be assessed before starting phototherapy, at 12 hrs interval during phototherapy and 24 hrs after stopping phototherapy.

Countries

India

Contacts

Public ContactMangalabharathi

Madras Medical College

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

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