Weight GainNCT04619758
Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
A study testing Emollient (sunflower oil) in people with Weight Gain, run by Dr. Abdul Ahad Jamshaid at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Emollient (sunflower oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Weight Gain
- Being tested
- Emollient (sunflower oil)
- Keywords
- Emollient Low birth weight Preterm Weight Length.
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Emollient Group | Experimental | Mothers of the neonates in group A will be advised massage with sunflower oil. Receives: Other: Emollient (sunflower oil) |
| Non-Emollient Group | No intervention | Mothers of the neonates in group B will be advised massage without any emollient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six Months
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.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Abdul Ahad Jamshaid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Abdul Ahad Jamshaid, King Edward Medical University
- Investigators
- Abdul Ahad Jamshaid, FCPS MRCPCH, Principal investigator, King Edward Medical University, Lahore, Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619758
- Sponsor's protocol ID
- 819/RC/KEMU
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25637007Jabraeile 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.
PubMed 27397955Akhavan 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.
PubMed 24639794Kumar 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.
PubMed 23054851Salam 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.
PubMed 24564550
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04619758
- Acronym / sponsor ID
- 819/RC/KEMU
- Conditions
- Weight Gain
- Keywords
- Emollient Low birth weight Preterm Weight Length.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dr. Abdul Ahad JamshaidUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emollient Group | Experimental | Other: Emollient (sunflower oil)Mothers of the neonates in group A will be advised massage with sunflower oil. |
| Non-Emollient Group | No intervention | –Mothers of the neonates in group B will be advised massage without any emollient. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Emollient Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 25637007Salam 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.
- Background: PubMed 27397955Jabraeile 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.
- Background: PubMed 24639794Akhavan 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.
- Background: PubMed 23054851Kumar 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.
- Background: PubMed 24564550Salam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Ahad Jamshaid, FCPS MRCPCH principal investigator
King Edward Medical University, Lahore, Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emollient (sunflower oil) in people with Weight Gain, run by Dr. Abdul Ahad Jamshaid at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Six Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619758, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.