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

Not Applicable

Completed

• Conditions: Weight Gain
• Interventions: Other: Emollient (sunflower oil)

• Registration Number: NCT04619758
• Lead Sponsor: Dr. Abdul Ahad Jamshaid

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Study First Submitted: 2020-10-26
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emollient Group	Emollient (sunflower oil)	Mothers of the neonates in group A will be advised massage with sunflower oil.

Primary Outcome Measures

Name	Time	Method
Change in Length	Six Months	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.
Change in Weight	Six Months	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.

Trial Locations

Locations (1)

King Edward Medical University; 🇵🇰 Lahore, Punjab, Pakistan