Objective: Evaluation of baby massage effects on billirubin level in patient with neonatal jaundice. Design: Randomized, single-blind, single-center, phase II trial. Setting and conduct: massage therapy and non-massage therapy is placed randomly into two groups. level of bilirubin is measured on the first, second, third and fourth day of hospitalization. Participants including major eligibility criteria: Inclusion criteria include Infants with neonatal jaundice have age between 2 to 14 days; exclusion criteria include preterm infants. Intervention: Infants in the intervention group will be underwent massage therapy and Infants in the control group will not be underwent massage therapy. main outcome measures variable: The level of total bilirubin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121610933N4
Registration date:2016-05-12, 1395/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Fatemeh Eghbalian
Name of organization / entity
Hamadan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 3978
Email address
eghbalian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of baby massage effects on billirubin level in patient with neonatal jaundice
Public title
effects of baby massage on billirubin level in neonatal jaundice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 2 to 14 days; full term newborn (gestational age between 38 to 40 weeks); weight of 2500 to 4000 gr; having indirect hyperbilirubinemia (TSB>16 mg/dl); absence of hemolysis, ABO or Rh incompatibility; negative coomb’s test; reticulocyte count less than 5%. Exclusion criteria: The neonates with sign of sepsis; electrolyte impairment; any congenital anomalies or disease; seizure; formula feeding; hemolytic disease and those who need exchange transfusion.
Age
From 2 days old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Mahdie Ave, Hamadan University of Medical Sciences, Hamadan, Iran.
City
Hamedan
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.umsha.REC.1394.140
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Total billirubin
Timepoint
First, second, third and fourth day of hospitalization
Method of measurement
RA1000 Techinca
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group under massage therapy plus phototherapy