The aim of this study is to determine the impact of developmental care on neonatal outcomes and maternal- child attachment in preterm infants. This study involved three groups with 35 cases in each group that will take place on babies with gestational age of 26 to 32 weeks with a birth weight less than 1500 g, born in Tabriz Alzahra Hospital, mechanical ventilation or CPAP initiated within 3 hours of birth and continued for at least 24 hours. The selections of control samples will be based on medical records of infants are admitted to the Alzahra NICU from September 2013 until the end of January 2014 (at this time not doing any developmental care). The selection of Intervention group 1 (Infants who received developmental care in NICU) and Intervention group 2 (Infants who received developmental care from delivery or operating room) will be based on inclusion and exclusion criteria and will be done from 2014 July. The sampling method in three groups will be based on convenience sampling. Outcomes will be include: clinical outcomes, infant development status based on ASQ at the corrected age of months 4, 8 and 12, development status based on the Bayley scale at corrected age of months 12 , maternal- child attachment status at corrected age of month 12 and finally cerebral structure status by MRI at the corrected age of month 12.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405175563N5
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Developmental Care on Short and Long- Term Outcomes and Mother-Infant Attachment in Preterm Infants.
Public title
The Effect of Developmental Care on Infant Outcomes and Mother-Infant Attachment in Preterm Infants.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The tendency of parents to participate in the study; Gestational age equal or less than 32 weeks with birth weight less than 1500 g; Infant is born in Tabriz Alzahra Hospital; Lack of maternal use of alcohol or drugs during pregnancy; Initiation of mechanical ventilation or CPAP within 3 hours of birth and continued for at least 24 hours.
Exclusion criteria:
Chromosomal abnormalities and congenital anomalies; Severe congenital infections; Infants need surgery; Dissuasion of parents from continuing to participate in the study.
Age
From 6 months old to 7 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Not 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
Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
9345
Health conditions studied
1
Description of health condition studied
Neonatal outcome
ICD-10 code
P 28.5
ICD-10 code description
Respiratory failure of newborn
Primary outcomes
1
Description
Length of stay in NICU
Timepoint
During discharging from the NICU
Method of measurement
Using researcher made questionnaire
2
Description
The need for respiratory support
Timepoint
During the stay in the NICU
Method of measurement
Using researcher made questionnaire
Secondary outcomes
1
Description
Development of Infant
Timepoint
At corrected ages of 4,8,12 and 24 months
Method of measurement
by Ages and Stages Questionnaire and Bailey Scale
Intervention groups
1
Description
Intervention group 1: Infants in this group will be received developmental care that includes the reducing light, reducing environment noise, nesting, manipulating of infants with slow movements, etc in NICU.
Category
Prevention
2
Description
Intervention group 2: Infants in this group will be received developmental care from operating or delivery room. Developmental care in the delivery or operating room include: increasing operating and delivery room temperature (25 ° C), reduction of light, getting and delivering the baby horizontally, delayed cord clamping 45-60 seconds, gentle manipulation the baby in the delivery or operating room
Category
Prevention
3
Description
Control group: Infants in this group will be received routine care in operating and delivery room and NICU.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Shirin Hasanpour Shater
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Golgasht Ave.
City
Tabriz
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 of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour Shater
Position
Midwifery Instructor
Other areas of specialty/work
Street address
South Shariati Ave., Nursing and midwifery Faculty
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical sciences
Full name of responsible person
Dr Elaheh Ouladsahebmadarek
Position
Associate Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1553 9160
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour Shater
Position
Midwifery Instructor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Shariati Ave.
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)