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Comparison between the effect of home visit training program and routine care on growth and development of preterm infants

Protocol summary

Summary
The present study aimed to investigate the effect of home visit training program on preterm infants’ growth and development within 6 months. In this double blind and clinical trial study, preterm infants were randomly divided into an intervention (N=30) and a control group (n=30). The person who collected the study outcomes remained blind to the outcome measures. Moreover, the researcher who train mothers was blined to the aim of the study.In addition, the statistician who performed the data analysis was kept blinded to the allocation, as well. The inclusion criteria of the study were gestational age under 37 weeks; being fed orally; and living in Shiraz. On the other hand, the exclusion criteria of the study were suffering from brain disorders; congenital cardiovascular diseases; metabolic or endocrine disorders; and known genetic and chromosomal abnormalities. The intervention group received home visit training program for 6 months, while the control group only received the hospital’s routine care. Then, the infants’ growth indexes, including weight, height, and head circumference, and development criteria such as following moving objects with the head, social laughing, keeping the head stable when changing position from lying to sitting, making “Agha” sound, taking objects by the hand, and laughing were compared in the first, second, third, and sixth months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082013690N3
Registration date: 2014-09-27, 1393/07/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-27, 1393/07/05
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Shiraz University of Medical Sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of home visit training program and routine care on growth and development of preterm infants
Public title
Effect of home visit training program on growth and development of preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria of the study were gestational age under 37 weeks; being fed orally; and living in Shiraz. On the other hand, the exclusion criteria of the study were suffering from brain disorders; congenital cardiovascular diseases; metabolic or endocrine disorders; and known genetic and chromosomal abnormalities.
Age
From 1 day old to 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Research Vice Chancellor, 7th floor, Centeral building of Shiraz University of Medical Sciences, Beside Helale Ahmar, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2008-09-22, 1387/07/01
Ethics committee reference number
ICR-87-4275

Health conditions studied

1

Description of health condition studied
preterm infants
ICD-10 code
P05.1
ICD-10 code description
Small for gestational age

Primary outcomes

1

Description
weight
Timepoint
First, second, third, and sixth month after birth
Method of measurement
gr

2

Description
Height
Timepoint
First, second, third, and sixth month after birth
Method of measurement
Meter (cm)

3

Description
Head circumference
Timepoint
First, second, third, and sixth month after birth
Method of measurement
Meter (cm)

Secondary outcomes

1

Description
Following moving objects with the head
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

2

Description
Social laughing
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

3

Description
Keeping the head stable when changing position from lying to sitting
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

4

Description
Making “Agha” sound
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

5

Description
Taking objects by the hand
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

6

Description
laughing
Timepoint
First, second, third, Fourth, fifth, and sixth month after birth
Method of measurement
Yes; No

Intervention groups

1

Description
Intervention group: Home visit program included familiarity with the differences between term and preterm infants, how to take care of a preterm infant, how to take care of umbilical cord, advantages of breastfeeding, how to hold the infant, and infant’s nutrition, and training about how to bath the infants and take care of them before and after bathing.
Category
Other

2

Description
Control group: No predefined program was executed in this group. They received the routine care and each mothers' questions were answered.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez
Full name of responsible person
Mitra Edraki
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Hazrat Zynab
Full name of responsible person
Mitra Edraki
Street address
City
Shiraz

3

Recruitment center
Name of recruitment center
Namaze
Full name of responsible person
Mitra Edraki
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Shiraz University of Medical Sciences
Full name of responsible person
Dr Ali Postfroush
Street address
Research Vice Chancellor, 7th floor, Centeral building of Shiraz University of Medical Sciences, Beside Helale Ahmar, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Faculty member
Other areas of specialty/work
Street address
Nursing and midwifery of Shiraz University of Medical Sciences, Namazee Square, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4258
Fax
Email
mitraedraki@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Master degree
Other areas of specialty/work
Street address
Nursing and Midwifery of Shiraz University of Medical Sciences, Namazee Square, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4258
Fax
Email
mitraedraki@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Master degree/ Faculty member
Other areas of specialty/work
Street address
Nursing and midwifery of Shiraz University of Medical Sciences, Namazee Square, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3646 4254
Fax
+98 71 3647 4252
Email
mitraedraki@yahoo.com
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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