Efficacy of Bala ashwagandhadi Taila Abhyanga (Massage) on improving weight gain and sleep quality in Low-Birth-Weight neonates (Alpabhara Shishu)- an open-labelled Randomized Comparative Clinical Trial.

Introduction

Low Birth weight infants born premature or small for gestational age constitute about 15 percent of neonates but account for 70 percent of all neonatal deaths infants born with low birth weight are at risk of linear growth faltering cognitive and motor deficits as well as lower academic performance and behavioural problems compared to normal birth weight infants Low Birth Weight harms child survival causing 40 to 80 percent of neonatal deaths owing to related complications stunted growth disabilities deficits in neurological development Ayurveda classical Acharya Charaka in Sharir Sthana has mentioned leena Garbhaupvishtaka nagodar and Garbha shosha which can be compared with IUGR babies due to maternal causes which ultimately leads to Low Birth Weight babiesThis is a comparative clinical trial where an herbal oil Balaashwagandhadi taila abhyanga massage will be compared with a traditionally used Coconut oil Narikela taila abhyanga Coconut oil massage has been proven to have positive results in weight gain velocity and length gain velocity in neonates

Methodology

Participants 50 per group

Sample size 100

Study design Randomized comparative clinical trial

Intervention

Group A  Abhyanga with Balashwagandhadi Taila twice per day for 15 min by mothers

Comparator

Group B  Abhyanga with Narikela Tailatwice per day for 15 min by mothers

Duration  6 weeks

Follow Up 2 weeks

Primary Objectives

To evaluate and compare the efficacy of Balaashwagandhaadi Taila Abhyanga oil massage and traditionally used Narikela Taila Abhyanga oil massage done according to the Ayurveda neonatal massage protocol for 15 minutes twice per day for 6 weeks on weight gain among LBW neonates

Secondary Objectives

To evaluate and compare the efficacy of Balaashwagandhadi Taila Abhyanga and     Narikela Taila Abhyanga on length head circumference and skinfold thickness among LBW neonates

To determine and compare the effect of Balashwagandhadi Taila Abhyanga and Narikela Taila abhyanga on quality of sleep among LBW neonates

To analyse and compare the effect of Balaashwagandhadi Taila Abhyanga and Narikela Taila Abhyanga on the Neonatal Behavioural Assessment Scale among LBW neonates

Inclusion Criteria

Clinically stable Low Birth Weight neonates 1500 grams to 2499 grams irrespective of sex and ethnicity

Born via NVD and LSCS with an APGAR score of more than 7 in the first minute of birth

Neonates with a history of LBW up to 6 months of age if weight is not appropriate to age at the time of assessment visiting the hospital for routine checkups and vaccination

Gestational age at birth should be above 28 weeks

 Exclusion Criteria

Very Low Birth Weight Neonates

Extremely preterm neonate

Skin Diseases Atopic Dermatitis napkin Rash contact dermatitis etc

Birth Injuries

Pathological Neonatal Jaundice

Major congenital anomaly newborn in NICU

Congenital Infections CNS Dysfunction for example Intraventricular Haemorrhage and History of Seizures

TPN Mechanical Ventilation and supplementary oxygen therapy

Neonates developing fever signs of sepsis respiratory distress necrotizing enterocolitis seizures neurological dysfunction or any other illnesses

Neonates sensitive to massage oil test dose

Criteria for Diagnosis

Low Birth weight 1500 grams to 2499 grams

Falling Below the tenth percentile on the growth chart or Small for gestation Age Neonates

Stable Preterm and IUGR Neonates

Withdrawal Criteria

Parents demanding withdrawal from the study

Noncompliance with study protocol

Mothers on narcotic agents barbiturates aspirin chloral hydrate reserpine and phenytoin sodium as medications

Outcomes

Primary Outcome

To achieve age appropriate improvement in weight gain velocity in Low birth weight neonates

Secondary Outcome

Age appropriate increase in length head circumference and skinfold thickness

Improvement in quality of sleep

Changes in the score of the Neonatal Behavioural Assessment Scale