Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized Controlled Clinical Trial
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ClinicalTrials.gov Identifier: NCT05944991 |
Recruitment Status :
Completed
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
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STUDY TITLE: Effect of olive oil massage on growth of preterm low birth weight neonate: A randomized controlled clinical trial."
SUMMARY:
Preterm low birth weight (LBW) babies have more the risk of the neurological complications, physiological problems and mental retardation. Topical massage with natural oil is routinely practiced in some country. The positive effects of massage are weight gain, improved sleep/wake pattern, decreased the stress, early discharge from the neonatal intensive care unit (NICU), improve the skin integrity and enhanced parent's infant bonding. This randomized control trial study will be conducted in the Department of Neonatology,Bangabandhu Sheikh Mujib Medical University(BSMMU) and post natal ward of Department of Obstetrics and Gynecology with the aim to assess the effect of olive oil message on growth in low birth weight neonate. In this study tolal 50 inborn low birth weight neonate will be enrolled. Out of which 25 will be in intervention group and 25 will be in control group. In the intervention group, mothers will be encouraged to massage their babies with 10 ml of olive oil for 15 min, twice a day until 10 days of life. Those allocated to the control group were received care as usual. Weight and head circumference was measured at enrolment, after 10 days and on 30 days of age in both the groups. Comparisons between groups for categorical variables will be performed using the χ2-test. Student's t-test will be used to compare two groups for normally distributed quantitative data. The difference will be considered significant for P < 0.05.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Weight Gain | Other: Olive oil message | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized |
Actual Study Start Date : | December 1, 2022 |
Actual Primary Completion Date : | May 31, 2023 |
Actual Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Olive oil message
Give olive oil message 2 times per day
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Other: Olive oil message
Message of olive oil 2 times daily |
- Effect of olive oil massage on growth of preterm low birth weight neonate: A randomized controlled clinical trial." [ Time Frame: 6 months ]To assess weight gain of preterm baby after olive oil message.
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Ages Eligible for Study: | 24 Hours to 1 Month (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:1. Babies with 1500 to 2499 grams birth weight. 2. Age 24 to 48 hours. 3. Babies on full breast feed 4.Hemodynamically stable babies.
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Exclusion Criteria:
-1. Newborns with multiple congenital anomalies 2. Preterm low birth weight neonate who required admission in NICU. 3. If there were symptoms such as fever, respiratory distress, muscle stiffness, vomiting.
4. Sensitivity to olive oil.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944991
Bangladesh | |
BSMMU | |
Dhaka, Bangladesh |
Responsible Party: | Rumpa Mani Chowdhury, Dr.Rumpa Mani Chowdhury, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
ClinicalTrials.gov Identifier: | NCT05944991 |
Other Study ID Numbers: |
11921 |
First Posted: | July 14, 2023 Key Record Dates |
Last Update Posted: | July 14, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Body Weight Birth Weight Weight Gain Body Weight Changes |