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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619758
• Other study ID #: 819/RC/KEMU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2020
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Weight Gain

Intervention

Other:
• Emollient (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.

Locations

Country	Name	City	State
Pakistan	King Edward Medical University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Abdul Ahad Jamshaid

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8. — View Citation

Jabraeile M, Rasooly AS, Farshi MR, Malakouti J. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial. Niger Med J. 2016 May-Jun;57(3):160-3. doi: 10.4103/0300-1652.184060. — View Citation

Kumar J, Upadhyay A, Dwivedi AK, Gothwal S, Jaiswal V, Aggarwal S. Effect of oil massage on growth in preterm neonates less than 1800 g: a randomized control trial. Indian J Pediatr. 2013 Jun;80(6):465-9. doi: 10.1007/s12098-012-0869-7. Epub 2012 Oct 4. — View Citation

Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30. — View Citation

Salam RA, Das JK, Darmstadt GL, Bhutta ZA. Emollient therapy for preterm newborn infants--evidence from the developing world. BMC Public Health. 2013;13 Suppl 3:S31. doi: 10.1186/1471-2458-13-S3-S31. Epub 2013 Dec 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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