Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04619758
Enrollment
140
Registered
2020-11-06
Start date
2018-01-01
Completion date
2018-06-30
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Gain

Keywords

Emollient Low birth weight Preterm Weight Length.

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.

Interventions

OTHEREmollient (sunflower oil)

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.

Sponsors

Dr. Abdul Ahad Jamshaid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in WeightSix MonthsNeonates 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.
Change in LengthSix MonthsNeonates 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026