The effect of breast milk odor on transitonal time from gavage to oral feeding in premature infants hospitalized in Nicu of Valiasr and comprehensie women hospital in 1392 in Tehran
Aim: The effect of odor stimulation with breast milk smell on feeding transitional time from gavage to oral feeding in premature infants hospitalized in intensive care unit in Valiasr and Comprehensive women hospital in Tehran in 2013
Inclusion and exclusion criteria: premature infants between 28-33 GA ; Minimmum weight of 1 kg ; Stable cardio-respiratory situation ; No ventriculare hemorahge ; No congenital anomallies
Population and samples: 92 premature infants (46 infants in control group and 46 infants as intervene group) hospitalised in neonatal intensive care of Valiasr and Comprehensive women hospital from April to 29 Aguast 2013.
Intervention:Odor stimulation with mother milk during gavage in study group.
Primary result: Transitional feeding time , hospital stay and first breast feeding time is shorter in study group .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031916538N1
Registration date:2014-03-19, 1392/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Atefeh Shamsi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2253 3762
Email address
b.pouraboli@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical Science of Kerman University
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breast milk odor on transitonal time from gavage to oral feeding in premature infants hospitalized in Nicu of Valiasr and comprehensie women hospital in 1392 in Tehran
Public title
The effect of mother' milk odor in gavage'weaning time in premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Incusion criteria:Infants with gestational age of 28-33 weeks ; Infants who had inability and weakness in sucking reflex according to Physician diagnosis ; Minimmum birth weight of 1 Kg ; Apgar score of more than 6 in minutes 1 and 5 ; Infants who were in an appropriate cardio-respiratory condition and had no
O2 saturation drop
Inclusion criteria: Dangeious anomallie for health ; Intra ventricular hemorrahages ; Resistance jundice in treatment
Age
From 28 years old to 33 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Kerman University of Medical Sciences
Street address
Haft Bagh Steet, Afzalipoor Pardizeh,
City
Kerman
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
کا/92/02
Health conditions studied
1
Description of health condition studied
Disorders related to short gestation and low birth weight, not elsewhere classified
ICD-10 code
P07
ICD-10 code description
Extremely low birth weight
Primary outcomes
1
Description
hospital stay
Timepoint
In discharge time
Method of measurement
Patient documentation
2
Description
first breast feeding time
Timepoint
Start of oral feeding
Method of measurement
cornometer
3
Description
weight
Timepoint
during study
Method of measurement
diital scale model tanita1583
4
Description
Transional time from gavage to oral feeding
Timepoint
In oral feeding start time
Method of measurement
Patient documentation
Secondary outcomes
empty
Intervention groups
1
Description
In study group we will stmulate infants with mothe'r milk odor pad during gavage in 9AM, 12MD, 3PM, 6PM during gavage feeding for minimmum 10 minute that will continiue to oral feeding time from breast.
Category
Other
2
Description
In control group we llnot do eny special intervention in spitr routin gavaging
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Valiasr Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Tehran Comprehensive Women Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kerman University of Medical Sciences
Street address
Haft Bagh Street, Afzalipoor Pardizeh, Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman Nursing Facaulty
Full name of responsible person
Atefeh Shamsi
Position
MBA of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Haft Bagh Street, Afzalipoor Pardizeh, Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 21 2253 3762
Fax
Email
noor13500@yahoo.comb.pouraboli@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Facaulty of Kerman
Full name of responsible person
Atefeh Shamsi
Position
MBA of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Haft Bagh, Afzalipoor Pardizeh, Kerman University of Medical sciences
City
Kerman
Postal code
Phone
+98 21 2253 3762
Fax
Email
noor13500@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Nursing Facaulty
Full name of responsible person
Atefeh Shamsi
Position
MBA of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Shahid Shakeri Alley, Ostad Hassan Bana Street,Northen Magidieh.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)