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Does Covering only the Head or Covering Both Head and Neck protect babies better from Low Calcium levels during Phototherapy

Comparison of Head vs Head & Neck covering in preventing Phototherapy induced Hypocalcemia in Neonates - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102411
Enrollment
100
Registered
2026-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P590- Neonatal jaundice associated withpreterm delivery Health Condition 2: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Head and neck covering: Neonates in this group will wear an integrated head and neck cap made of breathable, black colored cotton fabric during the entire duration of phototherapy (mini

Sponsors

Dr Mohamed Suhail M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All clinical neonatal jaundice babies receiving phototherapy who are less than or equal to Seven days old at the time of initiation of phototherapy

Exclusion criteria

Exclusion criteria: Neonates with sepsis, Existing hypocalcemia, those on calcium supplementation, or any other illness requiring NICU admission and refusal/withdrawal of informed parental consent

Design outcomes

Primary

MeasureTime frame
Incidence of receiving phototherapy induced hypocalcemia - defined as Total serum calcium less than 8mg/dl in term neonates or less than 7mg/dl in preterm neonatesTimepoint: Measured after 24 hours of phototherapy

Secondary

MeasureTime frame
Severity of Hypocalcemia categorized as Mild (7-8 mg/dl), Moderate (6-7mg/dl), Severe (less than 6mg/dl)Timepoint: After 24 hours of phototherapy;Change in serum calcium levels between pre phototherapy(baseline) value and post phototherapy(24 hours) valueTimepoint: Baseline to 24 hours post initiation of phototherapy;Neonatal comfort assessment using the Neonatal comfort scale with domains like facial expression, crying, alertness, vitals and behavioral stateTimepoint: During and immediately after the phototherapy session;Clinical signs of HypocalcemiaTimepoint: continuously monitored over the 24 hour phototherapy period

Countries

India

Contacts

Public ContactDr M Singaravelu

Vinayaka Mission s Medical College

drmsvelu159@gmail.com9443150520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026