One of the most common umbilical problems in neonates is umbilical granuloma, causing inflammation and drainage. This study was carried out to compare the effect of 2 and 24 hours salt (NaCl) in the treatment of neonatal umbilical granuloma. This is a controlled clinical trial study, done at neonatal NICU and infant Follow–up clinic of Emamreza hospital, Mashhad university of Medical sciences. 40 Neonates were randomly assigned to one of two groups. Group 1, including 20 infants with umbilical granuloma was undergone 24 hours treatment with salt group 2, including 20 infants was undergone 2 hours treatment with salt. In the first the salt was not washed out and or cleaned during this period. In the second group, the salt was washed by boiled water every 2 hours. The neonates were visited every day and healing process will be recorded. If there was no sign of healing, treatment with salt was continued until full recovery. Separation of umbilical cord and side effects was compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710021378N2
Registration date:2009-12-05, 1388/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-12-05, 1388/09/14
Registrant information
Name
Ahmadshah Farhat
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
farhata@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2005-12-31, 1384/10/10
Expected recruitment end date
2006-12-31, 1385/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two and twenty four hour treatment with salt in infant’s Umbilical Granuloma
Public title
Comparison of two and twenty four hour treatment with salt in infant’s Umbilical Granuloma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All neonates less than 1 month that were admitted in NICU or refered to clinic of Emamreza hospital.
Exclusion criteria: Presence of respiratory disorder, skin disorder, or infection diseases, very low birth weight neonates (birth weight less than 1500 grams)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Vice-chancellor for Research, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Postal code
91379-13131
Approval date
2008-12-14, 1387/09/24
Ethics committee reference number
5/9404
Health conditions studied
1
Description of health condition studied
umblical granuloma
ICD-10 code
P38
ICD-10 code description
Omphalitis of newborn with or without mild haemorrhage
Primary outcomes
1
Description
healing time of granuloma
Timepoint
Baseline and everyday till improvement of granuloma
Method of measurement
Observation of healing time by researcher
2
Description
Separation of umbilical cord
Timepoint
daily
Method of measurement
by observation
3
Description
side effects
Timepoint
daily
Method of measurement
Observation of redness, irritation, or inflammation
Secondary outcomes
empty
Intervention groups
1
Description
Granuloma was irrigated with boiled water and then was covered with powder of salt every 24 hours
Category
Treatment - Other
2
Description
Granuloma was irrigated with boiled water and then was covered with powder of salt every 2 hours
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Research Center
Full name of responsible person
Ahmad shah Farhat
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Tavakol Afshari
Street address
Ghorashi building, Daneshjoo street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
NRC, NICU, Emamreza hospital,
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, assistant professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ahmadshah Farhat
Position
Neonatologist, Assistant Professor
Other areas of specialty/work
Street address
NRC, NICU, Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
farhata@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)