Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial

Study Overview
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Brief Summary
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The objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.

Detailed Description
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The study will be conducted at the Department of Pediatric Medicine unit 1, KEMU / Mayo Hospital Lahore. Total of 140 neonates fulfilling the eligibility criteria will be enrolled. They will be randomly divided into two groups - A and B. Mothers of the neonates in group A will be advised massage with sunflower oil while mothers of the neonates in group B will be advised massage without any emollient. Babies will closely be followed up and their weight and length will be measured at six months of age and will be analyzed using SPSS v 23.0.

Official Title
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Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial

Conditions
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Weight Gain

Intervention / Treatment
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* Other: Emollient (sunflower oil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates of both genders Both breast fed and non-breast fed infants Neonates with birth weight between 1.5 and 2.5 kg Preterm neonates born between 28 and 37 completed weeks of gestation Exclusion Criteria: Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emollient Group<br>Mothers of the neonates in group A will be advised massage with sunflower oil. | Other: Emollient (sunflower oil)<br>* In group A, mothers will be advised to massage their babies with sunflower oil at a dose of 10 mL/kg/day twice a day in equally divided amounts. They will be called for follow up after six months of application of sunflower oil.<br>|
| No Intervention: Non-Emollient Group<br>Mothers of the neonates in group B will be advised massage without any emollient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Neonates will be called for follow up after 6 months of application of sunflower oil and their weights will be measured in kilograms using digital weighing scale. | Six Months | 
| Change in Length | Neonates will be called for follow up after 6 months of application of sunflower oil and their lengths will be measured in centimeters using infant length scale. | Six Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emollient Low birth weight Preterm Weight Length.