1. Home
  2. Approved trials
  3. » فارسی

Comparision the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy

Protocol summary

Study aim
Determine the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy
Design
A clinical trial with a control group and two intervention groups (massage and kangroo mother care), With parallel groupsfrom available samples without blindness, Randomized using random numbers table, Sample size 90 people,30 people in the control group, 30 people in the massage group and 30 people in the kangaroo care group.
Settings and conduct
90 term neonates with hyperbilirubinemia admite in emam khomeini and Aiatollah rohani hospital will be select and randomly divided into two intervention and one control groups. Conventional phototherapy was performed following the same procedure for all the neonates.
Participants/Inclusion and exclusion criteria
inclusion criteria: Gestational age 37-42 weeks, Birth weight 2500-4000 g, No therapeutic treatment drugs for hyperbilirubinemia, Age over 48h of birth, Bilirubin 15-20 mgr/dl exclusion criteria : ABO and Rh incompatibility,Possitive coombs,hemolysis, Bile duct and digestive tract obstruction,lack of glucose-6-phosphate dehydrogenase, Doubtful newborn to TORCH syndrom
Intervention groups
intervention group 1: kangaroo mother care (KMC): Along with phototherapy, KMC will be applied during breastfeeding at least five times over 24 h, for 3 consecutive days. intervention group 2: Field massage: Along with phototherapy, receive a 15-minute massage three times a day (morning, noon and evening), for 3 consecutive days. control group: The control group receives the routine care (phototherapy).
Main outcome variables
Evaluation of blood bilirubin reduction in patients in control and intervention groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180519039709N1
Registration date: 2018-08-06, 1397/05/15
Registration timing: registered_while_recruiting

Last update: 2018-08-06, 1397/05/15
Update count: 0
Registration date
2018-08-06, 1397/05/15
Registrant information
Name
Razie Lori kenari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3565 4906
Email address
R.lori@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy
Public title
Comparision the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 37-42 weeks Birth weight 2500-4000 g Apgar score from first to fifth minutes above 7 Receiving phototherapy for hyperbilirubinemia Breast feeding No drug to reduce bilirubin Age older 48 hours after birth Bilirubin 15-20 mgr/dl
Exclusion criteria:
ABO and Rh incompatibility, Possitivecoombs, hemolysis subgaleal hemorrhage, cephal hematoma, purpura Congenital anomaly infection Bile duct and digestive tract obstruction lack of glucose-6-phosphate dehydrogenase, Doubtful newborn to TORCH syndrom
Age
From 2 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, 90 term neonates with hyperbilirubinemia will be select and randomly divided into two intervention and one control groups.Randomization starts from a random point from a random number table and For a number of interventions, the intervention group and the control group are used a random permutation method, So that random numbers 0-4 for random permutation A B {(control B) (intervention A)} and Random numbers 5-9 are used for the random permutation B A {(Intervention A) (Control B)}.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Keshavarz St., Ganj Afrooz road, Baboll
City
Bobol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.011

Health conditions studied

1

Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
Neonatal blood bilirubin level
Timepoint
Measurement of Bilirubin level at 24, 48, and 72 h after phototherapy and Intervention
Method of measurement
Measurement of serum bilirubin levels in neonatal blood samples

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: kangaroo mother care (KMC):In the intervention group, in addition to standard phototherapy, KMC Will be apply by the mother. The mother after wearing a special gown laid on a folding bed, while the naked infant (wearing only a diaper and a hat) will be place between her breasts by a nurse. During hospitalization, KMC will be apply for 30-45 min at least five times a day in the morning, afternoon, and night.
Category
Treatment - Other

2

Description
Intervention group: Field massage : Massage Will be done with the soft parts of the fingers of both hands with light pressure by the researcher using field technique. Massage duration was 15 minutes, and include three steps each lasting five minutes, according to the same study. During the first and final stages, the infant is placed in prone position, and each minute one of the following areas is massage: A) 12 massage moves (every five seconds one move) from head downwards (both sides of the face to neck and reversely); B) 12 massage motions from the neck to the shoulders and reversely; C) 12 massage moves from the upper back down to the waist and reversely; D) 12 massage moves from the thighs down to the ankles and reversely; E) 12 massage motions from the shoulders to the wrists and reversely, in the middle phase, the infant was put in supine position and six extension and flexion moves were done (10 seconds for each) in the right arm, left arm, right leg, left leg, and both legs.
Category
Treatment - Other

3

Description
Control group: the newborns in the control group (age and weight similar to the intervention groups)is recived standarde phototherapy and only breastfeed by the mother, whereas KMC and massage do not apply.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam khomeini hospital
Full name of responsible person
parvin aziznejadroshan
Street address
Emam Ave
City
Fridonkenar
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
aziznejadroshan@yahoo.com

2

Recruitment center
Name of recruitment center
Aitollah Rohani hospitaL
Full name of responsible person
parvin aziznejadroshan
Street address
Keshavarz St, Ghanj afroze Ave
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
aziznejadroshan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza ghadimi
Street address
Keshavarz St, Ghanj afroz Ave
City
Bobol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
Fax
+98 11 3219 0181
Email
rezaghadimi@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Asistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Keshavarz St, Ghanj afroz Ave
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
aziznejadroshan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin aziznejadroshan
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Keshavarz St, Ghanj afroz St
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
aziznejadroshan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Razie Lori Kenari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shohada 20 Ave, Shohada St
City
Feridonkenar
Province
Mazandaran
Postal code
47519-36787
Phone
+98 11 3565 4906
Email
lori.kenari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...