| CTRI Number |
CTRI/2026/01/102411 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does Covering only the Head or Covering Both Head and Neck protect babies better from Low Calcium levels during Phototherapy |
|
Scientific Title of Study
|
Comparison of Head vs Head & Neck covering in preventing Phototherapy induced Hypocalcemia in Neonates - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohamed Suhail M |
| Designation |
1st year postgraduate - MD Paediatrics |
| Affiliation |
Vinayaka Mission’s Medical College |
| Address |
Vinayaka Mission’s Medical College,
Keezhakasakudimedu , Kottucherry (P.O)
Karaikal,
U.T. of Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9790075158 |
| Fax |
|
| Email |
thedocsuhail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Singaravelu |
| Designation |
Professor, Department of Paediatrics |
| Affiliation |
Vinayaka Mission’s Medical College |
| Address |
Vinayaka Mission’s Medical College,
Keezhakasakudimedu , Kottucherry (P.O)
Karaikal,
U.T. of Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443150520 |
| Fax |
|
| Email |
drmsvelu159@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Singaravelu |
| Designation |
Professor, Department of Paediatrics |
| Affiliation |
Vinayaka Mission’s Medical College |
| Address |
Vinayaka Mission’s Medical College,
Keezhakasakudimedu , Kottucherry (P.O)
Karaikal,
U.T. of Puducherry
PONDICHERRY
609609
India |
| Phone |
9443150520 |
| Fax |
|
| Email |
drmsvelu159@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission’s Medical College, Karaikal.
Keezhakasakudimedu, Kottucherry (P.O)
Karaikal - 609 609,
U.T. of Puducherry.
Material and infrastructure support
|
|
|
Primary Sponsor
|
| Name |
Dr Mohamed Suhail M |
| Address |
Vinayaka Mission’s Medical College, Karaikal.
Keezhakasakudimedu, Kottucherry (P.O)
Karaikal - 609 609,
U.T. of Puducherry.
|
| Type of Sponsor |
Other [Postgraduate student] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohamed Suhail M |
Vinayaka Missions Medical College and Hospital |
Department of Paediatrics, Neonatal Intensive Care Unit (NICU), First floor,
Keezhakasakudimedu, Kottucherry (P.O)
Karaikal - 609 609,
U.T. of Puducherry.
Karaikal
PONDICHERRY |
9790075158
thedocsuhail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL, KARAIKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P590||Neonatal jaundice associated withpreterm delivery, (2) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 (minimum of 24 hours) |
| Comparator Agent |
Head covering only |
Neonates in this group will wear a standard cap made of breathable, black colored cotton fabric covering the head only during the entire duration of phototherapy (minimum of 24 hours) |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
All clinical neonatal jaundice babies receiving phototherapy who are less than or equal to Seven days old at the time of initiation of phototherapy |
|
| ExclusionCriteria |
| Details |
Neonates with sepsis, Existing hypocalcemia, those on calcium supplementation, or any other illness requiring NICU admission and refusal/withdrawal of informed parental consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 neonates |
Measured after 24 hours of phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of Hypocalcemia categorized as Mild (7-8 mg/dl), Moderate (6-7mg/dl), Severe (less than 6mg/dl) |
After 24 hours of phototherapy |
| Change in serum calcium levels between pre phototherapy(baseline) value and post phototherapy(24 hours) value |
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 state |
During and immediately after the phototherapy session |
| Clinical signs of Hypocalcemia |
continuously monitored over the 24 hour phototherapy period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neonatal hyperbilirubinemia affects a majority of newborns and often requires phototherapy. A common complication is phototherapy induced hypocalcemia, potentially caused by light induced suppression of melatonin secretion by pineal gland. While studies suggest head covering reduces this risk, evidence is limited regarding whether extending coverage to the neck provides additional protection. This randomized controlled trial involving 100 neonates (less than or equal to 7 days old) aims to compare the effectiveness of head only covering versus combined head and neck covering in preventing Hypocalcemia. Participants will be randomized into two groups, Total serum calcium will be measured at baseline and after 24 hours of phototherapy. The study also evaluates neonatal comfort and the severity of any observed hypocalcemia. This simple, low cost intervention aims to optimize neonatal safety during phototherapy, particularly in resource limited settings. |