1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [rimjhim19sudipta@gmail.com].
   


6. For how long will this data be available start date provided 31-03-2026 and end date provided 31-03-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Introduction:

Neonatal jaundice is one of the most common clinical conditions encountered during neonatal period, characterized by yellowish discoloration of skin and sclera due to an increase in serum bilirubin. It can affect up to 60% of term and 80% of preterm neonates. This transient increase in serum bilirubin is multifactorial in aetiology, with immaturity of foetal liver and increased bilirubin production being the most important contributing factors. Other factors like inadequate breast feeding, dehydration and sepsis can also cause elevation in bilirubin. This is usually self-resolving, improving with liver maturity of the baby. However, a significant elevation can result in bilirubin crossing the blood brain barrier and deposition in various regions like basal ganglia, resulting in various acute and long-term effects of the same.

Phototherapy has long been used as a highly effective modality of treatment of neonatal jaundice. Phototherapy employs the principle of photo isomerisation of insoluble unconjugated bilirubin to a soluble product, which can be excreted by the kidneys without any requirement of conjugation by the liver. Blue- green light, in the range of 420-490 nanometres wavelength, is the most effective spectrum in photo isomerisation reaction.

In a low middle income country (LMIC) like India, administration of phototherapy may not be feasible at peripheral centres and also imposes a large financial burden. The blue- green spectrum present in natural sunlight could be potentially used for this purpose, to induce photo isomerisation of unconjugated bilirubin and reduce the serum bilirubin to safe levels. There is scant literature regarding employing sunlight for prevention or treatment of neonatal hyperbilirubinemia, though the existing studies suggest that prophylactic sunlight exposure may hold promise as a natural and cost-effective alternative to reduce the incidence and severity of neonatal jaundice, potentially minimizing the need for phototherapy. While the potential benefits of sunlight exposure are intriguing, comprehensive studies are essential to ascertain its efficacy and safety in a clinical setting.

This study aims to investigate the prophylactic use of sunlight exposure as a preventive measure against neonatal jaundice and, consequently, as a means to reduce the need for phototherapy in newborns. Additionally, we will assess the safety profile of sunlight exposure in newborns.

The significance of this research lies in its potential to offer a natural and accessible alternative source, particularly in resource-limited settings where access to medical interventions may be constrained. If proven effective, prophylactic sunlight exposure could not only reduce the burden on healthcare systems but also contribute to improved neonatal outcomes and overall infant well-being. As we embark on this study, the results may pave the way for innovative and holistic approaches to neonatal care, emphasizing the importance of harnessing the potential of nature in promoting the health and well-being of our youngest population.

Rationale

In low and middle-income country (INDIA), babies are at increased risk for jaundice for a number of reasons, poor access to maternal care during antenatal period, increased blood disorders causing jaundice, increased risk of infection, birth trauma. Sunlight emits light in a similar spectrum as of phototherapy. Sunlight is readily available, there is need to determine its efficacy in reducing the need of phototherapy. In low and middle-income countries phototherapy is not always available for babies who need it. Lack of robust evidence on usage of sunlight for prevention of neonatal jaundice.

Novelty

To best of our knowledge this is the first RCT on this topic in our country, exploring the preventive effects of sunlight on reducing the risk of significant neonatal jaundice and requirement of phototherapy.

Expected outcome and application

We expect the exposure of sunlight will prevent the occurrence of rate of significant neonatal jaundice needing intervention.

Research question(s):

In neonates ≥35^0/7 weeks (P), Does unfiltered sunlight exposure for 30 minutes, twice a day (I), compared to standard care (C), reduce the proportion of neonates requiring phototherapy (O)?

Research hypothesis:

Sunlight exposure for 30minutes, twice a day will reduce need of phototherapy in neonates of ≥35weeks.

Aim and objectives:

Aim:

To evaluate the efficacy of prophylactic unfiltered sunlight exposure in reduction of neonatal jaundice requiring phototherapy.

Objectives:

Primary objective(s)

To evaluate the efficacy of exposure of sunlight twice a day for half an hour in reducing the requirement of phototherapy till discharge or 5 days whichever is earlier, in neonates of ≥35 weeks of gestation when compared to standard care.

Secondary objective(s)

To study the

1.      Adverse effects associated   with sunlight exposure (hyperthermia, hypothermia, dehydration)

2.      Need of exchange transfusion, Duration of phototherapy.