Weight GainNCT05944991
Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized Controlled Clinical Trial
A study testing Olive oil message in people with Weight Gain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 hours to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Olive oil message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Dec 2022to 30 Jun 2023
- 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 24 hours to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized
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.
Read the detailed description
General Objective:
To observe the effect of Olive oil message on growth of preterm low birth weight babies.
Specific Objectives:
- To measure the growth of preterm low birth weight neonate with or without olive oil message groups.
- To measure the weight gain velocity of preterm low birth weight neonate with or without olive oil message groups.
- To compare the growth and weight gain velocity between of two groups.
Study design: Randomized control trial.
Place of study: Department of Neonatology and Department of Obstetrics \& Gynecology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka, Bangladesh.
Study period: 6 months after IRB clearance. Study population: All preterm low birth weight neonate who will stay with mother in post-natal ward.
Inclusion Criteria:
- Babies with 1500 to 2499 grams birth weight.
- Age 24 to 48 hours.
- Babies on full breast feed
- Hemodynamically stable babies.
Exclusion criteria:
- Newborns with multiple congenital anomalies
- Preterm low birth weight neonate who required admission in NICU.
- If there were symptoms such as fever, respiratory distress, muscle stiffness, vomiting.
- Sensitivity to olive oil.
Main outcome variable: Growth of the neonate
Study procedure:
All eligible neonate will be selected as per inclusion and exclusion criteria. After explaining the aims of the study and signing an informed consent by the parents, the neonates will be divided into two groups by using a table of random numbers generated by the computer. Group A will be served as the control group, here babies in this group will be get kangaroo mother care, nothing applied to skin as per institutional protocol. Group B will receive message with olive oil along with other care as per institutional protocol. Details of obstetric history, mode of delivery, the socioeconomic status, and presence of risk factors for sepsis will be noted in predesigned proforma in both group.
Mathai et al, has described a standardised massage protocol which has been followed by most studies on massage therapy and adopted in this study also [21]. The Mathai's massage therapy consists of both tactile and kinesthetic stimulation.
Inborn low birth weight neonates from the ages of 2 days will be chosen for the study. Two massage sessions will be given in a day, each session for 15 minutes. Oil massage will be given for 30 days. Mothers will be taught the techniques through demonstration by trained residents and will be encouraged to massage their babies. The massage session will be initiated an hour after a feed to avoid regurgitation or vomiting of the feed. The infant in the intervention group will be given olive oil (same brand) massage with 5mL/kg of body weight being applied per session. During massage, the neonates will be placed completely naked on a plastic cover. The mother will be instructed to warm and lubricate her hands before starting of massage and to remain silent during intervention. If the baby started crying or passed urine or stools during the session it will temporarily stopped till the baby will comfortable again. The massage protocol is as follows.
Phase I: This will be done in the prone position. Twelve firm strokes with palms of the hands of 5 seconds each, were provided in each area as follows: (a) Head from forehead hairline over scalp down to neck with alternate hands; (b) Neck from midline outwards with both hands simultaneously; (c) Shoulders from midline outwards with both hands simultaneousously; and (d) Back from nape of neck down to buttocks with firm, long stroke with alternate hands.
Phase-II: This will be done in the supine position. Twelve firm stroke with palms of the hands, of 5 seconds each, were provided in each area as follows: (a) Forehead - From midline, outwards with both hands simultaneously; (b) Cheeks - From side of nose, with both hands simultaneously in rotating and clockwise direction for left cheek and anticlockwise direction for right cheek; (c) Chest- 'butterfly' stroking from midline upwards, outwards, downwards and inwards back to initiating point; (d) Abdomen - From the appendix, in a clock wise direction around abdomen avoiding the epigastrium and probes, with gentle strokes; (e) Upper limbs (each separately)- from shoulders to wrist using alternate hands for stroking; ( f ) Lower limbs (each separately) - from hips to ankles using alternate hands for stroking; (g) Palms - from wrist to finger tips using alternate hands for stroking; and (h) Soles- from heel to toe tips using alternate hands for stroking.
Phase-III: This will be done in the supine position and consisted of passive flexion and extension movements of the limbs at each large joint (shoulder, elbow, hip, knee and ankle) as 5 events of 2 seconds each in each area. Those will be allocated to the control group will be received care as usual.
The weight,length,OFC of LBW neonate in both the groups will be measured and recorded on day of start message,10 days after and at 30 days. Regular communication with mother will be continue when they will be at home over phone.
In this way the study will be conducted for a period of 6 months and the data will be collected, tabulated and analysed.Adverse effects due to the massage will also looked for.
.
- Conditions
- Weight Gain
- Being tested
- Olive oil message
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oil messageOther
Message of olive oil 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| Olive oil message | Experimental | Give olive oil message 2 times per day Receives: Other: Olive oil message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of olive oil massage on growth of preterm low birth weight neonate: A randomized controlled clinical trial."
To assess weight gain of preterm baby after olive oil message.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rumpa Mani Chowdhury, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944991
- Sponsor's protocol ID
- 11921
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized
- ClinicalTrials.gov ID
- NCT05944991
- Acronym / sponsor ID
- 11921
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Jul 2023 (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.
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.
Detailed description
General Objective:
To observe the effect of Olive oil message on growth of preterm low birth weight babies.
Specific Objectives:
- To measure the growth of preterm low birth weight neonate with or without olive oil message groups.
- To measure the weight gain velocity of preterm low birth weight neonate with or without olive oil message groups.
- To compare the growth and weight gain velocity between of two groups.
Study design: Randomized control trial.
Place of study: Department of Neonatology and Department of Obstetrics \& Gynecology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka, Bangladesh.
Study period: 6 months after IRB clearance. Study population: All preterm low birth weight neonate who will stay with mother in post-natal ward.
Inclusion Criteria:
- Babies with 1500 to 2499 grams birth weight.
- Age 24 to 48 hours.
- Babies on full breast feed
- Hemodynamically stable babies.
Exclusion criteria:
- Newborns with multiple congenital anomalies
- Preterm low birth weight neonate who required admission in NICU.
- If there were symptoms such as fever, respiratory distress, muscle stiffness, vomiting.
- Sensitivity to olive oil.
Main outcome variable: Growth of the neonate
Study procedure:
All eligible neonate will be selected as per inclusion and exclusion criteria. After explaining the aims of the study and signing an informed consent by the parents, the neonates will be divided into two groups by using a table of random numbers generated by the computer. Group A will be served as the control group, here babies in this group will be get kangaroo mother care, nothing applied to skin as per institutional protocol. Group B will receive message with olive oil along with other care as per institutional protocol. Details of obstetric history, mode of delivery, the socioeconomic status, and presence of risk factors for sepsis will be noted in predesigned proforma in both group.
Mathai et al, has described a standardised massage protocol which has been followed by most studies on massage therapy and adopted in this study also [21]. The Mathai's massage therapy consists of both tactile and kinesthetic stimulation.
Inborn low birth weight neonates from the ages of 2 days will be chosen for the study. Two massage sessions will be given in a day, each session for 15 minutes. Oil massage will be given for 30 days. Mothers will be taught the techniques through demonstration by trained residents and will be encouraged to massage their babies. The massage session will be initiated an hour after a feed to avoid regurgitation or vomiting of the feed. The infant in the intervention group will be given olive oil (same brand) massage with 5mL/kg of body weight being applied per session. During massage, the neonates will be placed completely naked on a plastic cover. The mother will be instructed to warm and lubricate her hands before starting of massage and to remain silent during intervention. If the baby started crying or passed urine or stools during the session it will temporarily stopped till the baby will comfortable again. The massage protocol is as follows.
Phase I: This will be done in the prone position. Twelve firm strokes with palms of the hands of 5 seconds each, were provided in each area as follows: (a) Head from forehead hairline over scalp down to neck with alternate hands; (b) Neck from midline outwards with both hands simultaneously; (c) Shoulders from midline outwards with both hands simultaneousously; and (d) Back from nape of neck down to buttocks with firm, long stroke with alternate hands.
Phase-II: This will be done in the supine position. Twelve firm stroke with palms of the hands, of 5 seconds each, were provided in each area as follows: (a) Forehead - From midline, outwards with both hands simultaneously; (b) Cheeks - From side of nose, with both hands simultaneously in rotating and clockwise direction for left cheek and anticlockwise direction for right cheek; (c) Chest- 'butterfly' stroking from midline upwards, outwards, downwards and inwards back to initiating point; (d) Abdomen - From the appendix, in a clock wise direction around abdomen avoiding the epigastrium and probes, with gentle strokes; (e) Upper limbs (each separately)- from shoulders to wrist using alternate hands for stroking; ( f ) Lower limbs (each separately) - from hips to ankles using alternate hands for stroking; (g) Palms - from wrist to finger tips using alternate hands for stroking; and (h) Soles- from heel to toe tips using alternate hands for stroking.
Phase-III: This will be done in the supine position and consisted of passive flexion and extension movements of the limbs at each large joint (shoulder, elbow, hip, knee and ankle) as 5 events of 2 seconds each in each area. Those will be allocated to the control group will be received care as usual.
The weight,length,OFC of LBW neonate in both the groups will be measured and recorded on day of start message,10 days after and at 30 days. Regular communication with mother will be continue when they will be at home over phone.
In this way the study will be conducted for a period of 6 months and the data will be collected, tabulated and analysed.Adverse effects due to the massage will also looked for.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olive oil message | Experimental | Other: Olive oil messageGive olive oil message 2 times per day |
Who may qualify
- Ages
- 24 hours to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- -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.
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 |
|---|---|---|
| Olive oil messageMessage of olive oil 2 times daily | Other | Olive oil message |
Primary outcome
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.
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 14 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil message in people with Weight Gain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 0 inclusion and 2 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 14 Jul 2023. 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 Bangladesh. 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?
Effect of olive oil massage on growth of preterm low birth weight neonate: A randomized controlled clinical trial." (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.