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 - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  After completion of analysis, the research will be sent for publication to international neonatal journals or if unapproved then to indian journals of pediatrics.


6. For how long will this data be available start date provided 01-05-2026 and end date provided 31-12-2090?
   Response - Immediately following publication. No end date.
   


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

Neonates admitted in NICU for various indications universally undergo some painful procedures in form of venepunctures and cannulation for blood testing. Such painful procedures in neonates have the capability to alter their homeostasis, creating an “allostatic load” rendering them prone to derangement in their physiology. Their inability to fully express themselves and subtle signs have the potential to be missed in events of painful procedures. Pharmacological methods for pain reduction applied in adults cannot be extrapolated in neonatal science. Many drugs become contraindicated and more often studies and evidence on their safety profile and side effects are lacking. This forces us to utilize non-pharmacological, neonatal friendly alternatives like breast feeding, kangaroo mother care (KMC) and administration of sweet substances like dextrose which have shown to be effective in reducing neonatal pain as evident in number of studies. While administration of 25% dextrose (osmolarity 1390 mOsm/L) has been found to be most effective in reducing pain in neonates in some studies and is routinely followed in some neonatal intensive care units, it is known that administration of hypertonic solutions to neonates result in adverse effects of vomiting and feed intolerance. Though multiple comparative studies between dextrose and breastmilk have been conducted, volume-based studies using different dextrose concentrations with same sugar amount is lacking. Such a study would aid in determining if low osmolarity sweet solutions (like 10% dextrose - osmolarity 505 mOsm/L) and breast milk (osmolarity 300 mOsm/L) with same sugar content can be as effective in producing analgesia in newborn babies thus preventing unnecessary administration of hypertonic solutions to the newborn. Therefore, this study holds the research hypothesis that there is an effect of 5 ml of 10% Dextrose and 7 ml of expressed breast milk in reducing procedural pain in term neonates as compared to 2 ml of 25% Dextrose as measured by premature infant pain profile score.

 In this study 135 term neonates (whose parents have consented for participating in study) admitted to NICU for neonatal jaundice requiring only phototherapy will be included. During routine sampling for total serum bilirubin, 5 ml of 10% dextrose OR 2 ml of 25 % dextrose OR 7 ml of mother’s expressed breast milk will be administered orally two minutes before sampling using a paladai. Sampling will be done as per the protocol for neonatal jaundice treatment. Baseline RBS will be taken and neonatal response to pain using PIPP score (premature infant pain profile score) will be recorded. One repeat RBS after one hour of administering solution will be taken. No extra sampling of the baby will be done. The responses will be recorded in a sheet of paper for later analysis which will be hidden from investigators till all data collection is complete. This will be a double blind, prospective, parallel group, randomised control trial and data analysis will be carried out using latest software.