1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


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 - Proposals should be directed to [kpkarthik131@gmail.com].
   


6. For how long will this data be available start date provided 30-05-2024 and end date provided 30-05-2029?
   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

Perinatal events have a profound impact on the growth, development, and adult life of a child. Insults and injuries in the neonatal period are associated with chronic neurodevelopmental, cognitive, and behavioral complications often lacking complete reversal. Hence preventive neonatology is a domain of public health interest. Kaumarabhritya or Ayurvedic pediatrics begins with neonatal care and has multiple unique practices. They are unresearched by the Ayurvedic fraternity despite their documented benefits. Massage is a multifaceted modality mentioned in Ayurveda and has been researched worldwide. This study aims to compare the add-on efficacy of oil massage using Ayurvedic polyherbal oils in managing neonatal jaundice, stress, oxidative stress, and hypothermia, explore the bilirubin-lowering action of Ayurvedic herbs at the cellular level, and compile the newborn care practices in Ayurvedic hospitals and educational institutes.

Methodology

Participants per group: Sample Size: 70

Study Design: Randomized Active Controlled Trial

Intervention: Oil massage shall be done as per the Ayurveda Neonatal Massage Therapy Protocol (ANMTP) (each session of 15 minutes) twice a day for a week in addition to Neonatal resuscitation, routine care, phototherapy.

Comparator: Neonatal resuscitation, routine care, phototherapy.

Primary Objective

·       To compare the add-on efficacy of oil massage (abhyanga) with Arukaladi taila done using Ayurveda neonatal massage therapy protocol for 15 minutes with moderate pressure twice a day for two to seven days in addition to standard newborn care in reducing the total serum bilirubin levels in neonates compared to those receiving standard newborn care alone.

Secondary Objective

·       To evaluate the add-on efficacy of oil massage with Bala taila in addition to standard newborn care on perinatal stress indicated by salivary cortisol levels of newborns.

·       To compare thermoregulation in neonates receiving oil massage and SNC against those receiving SNC alone (indicated by mean body temperature).

·       To compare the insulin-like growth factor 1, in neonates receiving oil massage and SNC against those receiving SNC alone.

·       To evaluate the antioxidant efficacy of neonatal massage by comparing Glutathione reduced/oxidized ratio and Malondialdehyde in neonates receiving oil massage and SNC against those receiving SNC alone.

·       To evaluate the efficacy of neonatal massage by comparing the adverse reaction against phototherapy via symptomatic assessment.

·       To evaluate the bilirubin-lowering action of Eclipta alba (Linn.) Hassk (Bhringaraja) hydroalcoholic extract in HepG2 (human liver) cell lines in terms of its effect on uridine diphosphogluconurate glucuronosyltransferase (UGT1A1) expression.

·       To collect information about practices related to neonatal care in Ayurvedic hospitals and educational institutions.

Inclusion Criteria:

1.     Healthy Neonates immediately after birth, irrespective of sex and ethnicity

2.     Gestational age >28 weeks, birth weight > 1500 g

3.     An APGAR Score of more than 7 in the first minute.

4.     Neonates who do not require oxygen support, positive ventilation, or parenteral nutrition.

5.     Neonates fulfilling KA87 (neonatal hyperbilirubinemia) clinical features as per ICD-11.

Exclusion Criteria:

1.     Extremely preterm neonates (<1500g)

2.     Extremely Low Birth Weight (<28 weeks)

3.     Rhesus and ABO incompatibility, G6PD deficiency.

4.     Birth injuries

5.     Congenital anomalies

6.     Signs of infection, intraventricular or subgaleal hemorrhage,

7.     Signs of gastrointestinal obstruction, or biliary atresia.

8.     Neonates who are on/require oxygen support, positive ventilation, parenteral nutrition, or other intravenous infusions.

9.     Neonates expressing hypersensitivity to oil test dose.

10.  Neonates whose both parents are minors.

11.  Mothers receiving drugs narcotic agents, barbiturates, aspirin, chloral hydrate, reserpine, and phenytoin sodium pre- or post-parturition.

1.1.1.     Diagnostic Criteria

·       Neonatal hyperbilirubinemia shall be diagnosed based on Total Serum bilirubin levels, i.e., above 95^th percentile of TSB distribution.

·       Severe neonatal hyperbilirubinemia shall be considered in case of onset before 24 hours and jaundice necessitating phototherapy.