Back to resultsEmollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Primary Purpose
Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Emollient (sunflower oil)
Sponsored by
About this trial
This is an interventional supportive care trial for Weight Gain focused on measuring Emollient Low birth weight Preterm Weight Length.
Eligibility Criteria
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.
Sites / Locations
- King Edward Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Emollient Group
Non-Emollient Group
Arm Description
Mothers of the neonates in group A will be advised massage with sunflower oil.
Mothers of the neonates in group B will be advised massage without any emollient.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04619758
First Posted
October 26, 2020
Last Updated
November 2, 2020
Sponsor
Dr. Abdul Ahad Jamshaid
1. Study Identification
Unique Protocol Identification Number
NCT04619758
Brief Title
Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Official Title
Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Abdul Ahad Jamshaid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
Emollient Low birth weight Preterm Weight Length.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emollient Group
Arm Type
Experimental
Arm Description
Mothers of the neonates in group A will be advised massage with sunflower oil.
Arm Title
Non-Emollient Group
Arm Type
No Intervention
Arm Description
Mothers of the neonates in group B will be advised massage without any emollient.
Intervention Type
Other
Intervention Name(s)
Emollient (sunflower oil)
Intervention Description
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 Outcome Measure Information:
Title
Change in Weight
Description
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.
Time Frame
Six Months
Title
Change in Length
Description
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.
Time Frame
Six Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ahad Jamshaid, FCPS MRCPCH
Organizational Affiliation
King Edward Medical University, Lahore, Pakistan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Edward Medical University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25637007
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.
Results Reference
background
PubMed Identifier
27397955
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.
Results Reference
background
PubMed Identifier
24639794
Citation
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.
Results Reference
background
PubMed Identifier
23054851
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.
Results Reference
background
PubMed Identifier
24564550
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(Suppl 3):S31. doi: 10.1186/1471-2458-13-S3-S31. Epub 2013 Dec 20.
Results Reference
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Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
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