Clinical trial NCT06595368: Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia
Official title: Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet
timeFrame: Daily measurement from first day of neonate's admission to day 5 of admission
measure: Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet
timeFrame: Daily measurement from first day of neonate's admission to day 5 of admission
measure: 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
timeFrame: Daily measurement from first day of neonate's admission to day 5 of admission
measure: Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet
timeFrame: Daily measurement from first day of neonate's admission to day 5 of admission
Secondary outcomes:
measure: Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool
timeFrame: through 5 days from admission
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr el-Sheikh
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr el-Sheikh
Study officials:
References: