Protocol summary

Summary
Purpose: Comparison the effect of Syntetice Purgative Manna drop (Bilinaester drop) and massage therapy on neonatal bilirubin that were under treatment of phototherapy. Design: This study was a randomized controlled clinical trial of three groups (one control and two intervention groups). Inclusion criteria: gestational age 35-42 week, Serum total bilirubin 12-24 mg /dl, birth weight >2000 grams. Exclusion criteria: infection, asphyxia, Indications for blood exchange. Study population: All nearly or full-term neonatales that they have inclusion criteria. Sample size: 72 neonate 2 to 15 days. interventions: The first group (control) will be received standard treatment (phototherapy ). The second group (Bilinaester drop intervention) will be treated with photothrapy and Bilinaester drop by three drops per kg three times a day. In third group ( massage intervention) infants received " Field" massage in addition to conventional phototherapy." Field" Massage was performed thrice daily (morning، noon and afternoon) for 15 minutes each and after feeding. Before the massage, the hands of the researcher were warmed to the body temperature of the infant.this technique included three steps each lasting five minutes. During the first and final stages, the infant was placed in prone position, and each minute one of the following areas was massaged: 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. phototherapy devices were randomly used in the cases and control groups. main outcome measures: Serum billirubin level was assayed on arrival at the hospital. Then daily measuring of bilirubin will be continued until the baby is discharged.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101830370N1
Registration date: 2016-11-14, 1395/08/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Fateme Pasban
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1513
Email address
pasbanf911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Syntetice Purgative Manna Drop and Massage on Neonatal Jundic under Photothropy
Public title
Comparison the Effect of Syntetice Purgative Manna Drop and Massage on Neonatal Jundic under Photothropy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age 35-42 week, birth weight over 2000 grams, total bilirubin12-24 mg/dl. Exclusion criteria: Indications for blood exchange transfusion, infection, asphyxia
Age
From 2 days old to 15 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah St
City
Mashhad
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
940442.1.852

Health conditions studied

1

Description of health condition studied
neonatal hyperbilirubinemia
ICD-10 code
59.9
ICD-10 code description
Neonatal Jaundice

Primary outcomes

1

Description
Unknown Hyperbilirubinemia
Timepoint
At admision
Method of measurement
Questionnaire, Laboratory Test

Secondary outcomes

1

Description
Bilirubine level
Timepoint
At admision, phototherapy, discharge time
Method of measurement
At admision, phototherapy, discharge time

Intervention groups

1

Description
control group: neonatal will be received only phototherapy and standard treatment
Category
Treatment - Other

2

Description
massage intervention group: infants will be received " Field" massage in addition to conventional phototherapy." Field" Massage was performed thrice daily (morning، noon and afternoon) for 15 minutes each and after feeding. Before the massage, the hands of the researcher were warmed to the body temperature of the infant.this technique included three steps each lasting five minutes. During the first and final stages, the infant was placed in prone position, and each minute one of the following areas was massaged: 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
Bilinaester drop intervention group: Neonatal will be treated with photothrapy and Bilinaester drop by three drops per kg three times a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand Valeasr Hospital
Full name of responsible person
Gharaei docter
Street address
Childeren Unit, Valeasr Hospital, Ghafari st
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi, Vice chancellor for research
Street address
Vice chancellor for research، Mashhad University of Medical Sciences, Daneshgah St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Pasban
Position
Student of Master of Sciences in Nursing Neonatal Intensive Care
Other areas of specialty/work
Street address
Nursing of college, Daneshgah St
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
+98 51 3859 1513
Email
pasbanf911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebe Rahani
Position
Master of Sciences
Other areas of specialty/work
Street address
Nursing of college, Daneshgah St
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
+98 915 122 9727
Email
rahanit@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebe Rahani
Position
Master of Sciences
Other areas of specialty/work
Street address
Nursing of college, Daneshgah St
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
+98 915 122 9727
Email
rahanit@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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