Some research has shown that factors such as Skin Contact between mother and newborn, sucking on a pacifier or an empty breast feeding can be affecting the infant's development. The purpose In this study we examine the effect of pacifier sucking breast empty for growth of preterm infants admitte to Children's Hospital and Shariati in Bandar Abbas in 2012. Inclusion Criteria: Informed consent of the mother, age between 32-26 weeks and birth weight less than 1500 g.Exclusion Criteria: Neonates with severe asphyxia, malformations, cranial hemorrhage grade 3 or 4 infections at the onset or during the study and very ill newborns. In this experimental study, 69 infants will be selected and divided into three groups. Group I and Group II oral stimulation by breast-received by the pacifier in the morning and afternoon for 10 minutes. In the third group, who were selected as the control group, received no intervention. The growth parameters including weight, head circumference, weekly and daily until discharge is measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120815458N2
Registration date:2014-01-03, 1392/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Rakhshane Goodarzi
Name of organization / entity
Hormozgan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 76 1666 6242
Email address
rgoodarzi@oldhums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of non-nutritive sucking and feeding in preterm infants growth,that admitted to Children's Hospital and Shariati in Bandar Abbas in 2012.
Public title
The effect of sucking in preterm infants without give milk that admitted to hospital
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria: Informed consent of the mother, age between 32-26 weeks and birth weight less than 1500 g.
Exclusion Criteria: Neonates with severe asphyxia, malformations, cranial hemorrhage grade 3 or 4 infections at the onset or during the study and very ill newborns
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd., beside the Governor
City
Bandarabbas
Postal code
Approval date
2013-08-12, 1392/05/21
Ethics committee reference number
HEC-92-5-21-2
Health conditions studied
1
Description of health condition studied
Development of feeding in preterm infants
ICD-10 code
P05-P08
ICD-10 code description
Disorders related to length of gestation and fetal growth
Primary outcomes
1
Description
Amount of weight infants
Timepoint
Daily after feeding the infant
Method of measurement
Rasa microbalance
2
Description
Head circumference
Timepoint
Weekly
Method of measurement
Centimeter
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Admission until discharge
Method of measurement
daily
Intervention groups
1
Description
In interventional group: neonates stimulate every day, 2 times for 15 minutes for 10 days and the breastfeeding will be done free from milk or a pacifier. Until the start of oral feeding in preterm infants.Oral intake begin when neonates stable clinically and hemodynamically.Depending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the micro-balance RASA will be done. Weight and head circumference will be analyzed.
Category
Diagnosis
2
Description
In control group :neonates will not stimulate with the breastfeeding or pacifier .Oral intake begin when neonates stable clinically and hemodynamicallyDepending on the Physical conditions , oral feeding newborn will be done 20 ml per kilogram per day. Weight and head circumference will be measured at baseline. Then weekly head circumference and weight will be measured daily. Also at the time of discharge, head circumference, and weight will be recorded. Weight recorded by one person and used directly in the micro-balance RASA will be done. Weight and head circumference will be analyzed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Street address
City
Bandar Abbas
2
Recruitment center
Name of recruitment center
Children's Hospital
Full name of responsible person
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Doctor Rakhshaneh Goodarzi
Street address
Golshahr, Children's Hospital of Bandar Abbas
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Rakhshaneh goodarzi
Position
Neonatologist, Academic staff
Other areas of specialty/work
Street address
Children's Hospital of Bandar Abbas,Golshahr
City
Bandar Abbas
Postal code
Phone
+7 616676291
Fax
Email
Rgoodarzi@oldhums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Rakhshaneh goodarzi
Position
Neonatologist, Academic staff
Other areas of specialty/work
Street address
Children's Hospital of Bandar Abbas,Golshahr
City
Bandar Abbas
Postal code
Phone
+98 76 1667 6291
Fax
Email
Rgoodarzi@oldhums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Rakhshaneh goodarzi
Position
Neonatologist, Academic staff
Other areas of specialty/work
Street address
Children's Hospital of Bandar Abbas,Golshahr
City
Bandar Abbas
Postal code
Phone
+98 76 1667 6291
Fax
Email
Rgoodarzi@oldhums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)