Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05944991
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-07-06
Brief Title:
Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate A Randomized Controlled Clinical Trial
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate A Randomized
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Topical massage with natural oil is routinely practiced in some country The positive effects of massage are weight gain improved sleepwake pattern decreased the stress early discharge from the neonatal intensive care unit NICU improve the skin integrity and enhanced parents infant bonding This randomized control trial study will be conducted in the Department of NeonatologyBangabandhu Sheikh Mujib Medical UniversityBSMMU 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 Students t-test will be used to compare two groups for normally distributed quantitative data The difference will be considered significant for P 005
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 sleepwake pattern decreased the stress early discharge from the neonatal intensive care unit NICU improve the skin integrity and enhanced parents infant bonding This randomized control trial study will be conducted in the Department of NeonatologyBangabandhu Sheikh Mujib Medical UniversityBSMMU 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 Students t-test will be used to compare two groups for normally distributed quantitative data The difference will be considered significant for P 005
Detailed Description:
General Objective
To observe the effect of Olive oil message on growth of preterm low birth weight babies
Specific Objectives
1 To measure the growth of preterm low birth weight neonate with or without olive oil message groups
2 To measure the weight gain velocity of preterm low birth weight neonate with or without olive oil message groups
3 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
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
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
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 Mathais 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 5mLkg 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 weightlengthOFC of LBW neonate in both the groups will be measured and recorded on day of start message10 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 analysedAdverse effects due to the massage will also looked for
To observe the effect of Olive oil message on growth of preterm low birth weight babies
Specific Objectives
1 To measure the growth of preterm low birth weight neonate with or without olive oil message groups
2 To measure the weight gain velocity of preterm low birth weight neonate with or without olive oil message groups
3 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
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
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
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 Mathais 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 5mLkg 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 weightlengthOFC of LBW neonate in both the groups will be measured and recorded on day of start message10 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 analysedAdverse effects due to the massage will also looked for
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None