Neonatal Jaundice
Conditions
Brief summary
The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.
Detailed description
The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow: Control Group: Consisted of 30 newborns who will receive conventional hospital care with no additional interventions. Study Group (I): Consisted of 30 neonates who will receive Vimala massage. The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift. Study Group (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min.
Interventions
PROCEDUREVimala massage
The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.
PROCEDUREHydrotherapy
Hydrotherapy will be applied two times per day before feeding, each lasting 5-10 min.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
Yes
Inclusion criteria
full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal
Exclusion criteria
* major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet | Daily measurement from first day of neonate's admission to day 5 of admission | Total serum bilirubin level monitoring sheet: it includes 2 tests of total serum bilirubin level & indirect serum bilirubin tests. The daily measurement will be done, its primary purpose is to evaluate the effect of Vimala massage and hydrotherapy on newborns with Jaundice undergoing phototherapy. Bilirubin will be measured using microassay. |
| Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet | Daily measurement from first day of neonate's admission to day 5 of admission | Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight |
| Change from baseline of neonate's number of diaper exchange to monitor the frequency of defection and amount of stool on Bilirubin excretion monitoring sheet | Daily measurement from first day of neonate's admission to day 5 of admission | Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool |
| Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet | Daily measurement from first day of neonate's admission to day 5 of admission | Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool | through 5 days from admission | Clinical efficacy monitoring tool was developed by researchers after a review of relevant literature to assess the effectiveness of Vimala massage and Hydrotherapy in accelerating the regression time of jaundice. |
Countries
Egypt
Outcome results
None listed