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Completed

NCT Number: NCT04619758

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

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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University

Lahore, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emollient (sunflower oil)

Other

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.

Primary outcomes

  1. Change in Weight

    Time frame: 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.

  2. Change in Length

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Abdul Ahad Jamshaid

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2020
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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