Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05944991 |
| Other study ID # |
11921 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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 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.
.
