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

Dr. Abdul Ahad Jamshaid

Status: Completed

Conditions: Weight Gain

Treatments: Other: Emollient (sunflower oil)

Study type: Interventional

Funder types: Other

Identifiers

NCT04619758

819/RC/KEMU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Emollient Group

Experimental group

Description:

Mothers of the neonates in group A will be advised massage with sunflower oil.

Treatment:

Other: Emollient (sunflower oil)

Non-Emollient Group

No Intervention group

Description:

Mothers of the neonates in group B will be advised massage without any emollient.