Preterm birth is the most common cause of death in babies and as one of the risk factors is intended for developmental disabilities Which can lead to long-term effects on the Neuromuscular development. Since the original development is done during pregnancy, especially during the last months and weeks and the babies are born too early, so had ample opportunity for the development of critical systems developmental and physiological problems may have multiple.Multi-sensory stimulation is relatively new intervention to simulate the environment in the first weeks of intrauterine life; to maintain and facilitate the development in premature infants.This study aimed to effect of multi-sensory stimulation on the development of neuromuscular, weight and physiological parameters in preterm infants.In this clinical trial, 80 preterm infants with gestational age between 32 and 36 weeks were assigned randomly into two groups and controlled multisensory stimulation.Groups intervention, multisensory stimulation program for 12 minutes a day, 5 times a week at a time until discharge and the control group received only usual care.Physiological parameters (respiration, heart rate, blood pressure and oxygen saturation) using the monitoring and the development of neuromuscula using the Infant Neurological International Battery before and after the intervention, as well as daily weight gain the researcher measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073114454N2
Registration date:2016-08-17, 1395/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-17, 1395/05/27
Registrant information
Name
Fatemeh Nasimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 72 1222 4259
Email address
nasimif911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Jahrom University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-09-02, 1395/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multi-sensory stimulation on the development of neuromuscular, weight and physiological parameters in preterm infants
Public title
The effect of multi-sensory stimulation on the development of neuromuscular, weight and physiological parameters in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: parental consent; infants age between 37-30 weeks; hemodynamic stability (HR=120-160, RR=30-50, SPO2=85%-95% and keep axillary temperature range of 37-36 Centigrade degrees ); Apgar scores of 7 or more on the first and fifth minutes of birth; spontaneous ventilation and no need for ventilation; lack of congenital malformations. Exclusion criteria: lack of consent to continue working for any reason; ventilation need during the study; infants with recurrent Apnea; seizures during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahari Street, Jahrom
City
Jahrom
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.JUMS.REC.1394.207
Health conditions studied
1
Description of health condition studied
Preterm infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Heart Rate
Timepoint
Before and after the intervention.
Method of measurement
with monitoring
2
Description
Blood Pressure
Timepoint
Before and after the intervention.
Method of measurement
with monitoring
3
Description
Oxygen Saturation
Timepoint
Before and after the intervention.
Method of measurement
with monitoring
4
Description
Respiration Rate
Timepoint
Before and after the intervention.
Method of measurement
with monitoring
Secondary outcomes
1
Description
Neuromuscular development
Timepoint
Before and after the intervention.
Method of measurement
Using tool Infant Neurological International Battery
2
Description
Weight gain
Timepoint
Daily
Method of measurement
Using the Balance
Intervention groups
1
Description
The intervention group receive multi-sensory stimulation for 12 minutes every day, 5 times a week until discharge
Category
Prevention
2
Description
The control group received usual care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit, Motahari Hospital
Full name of responsible person
Fatemeh Nasimi
Street address
Neonatal Intensive Care Unit, Motahari Hospital, Motahari Street, Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Jahrom University of Medical Sciences
Full name of responsible person
Dr. Kavus Solhjo
Street address
Jahrom University of Medical Sciences, Motahari Street, Jahrom
City
Jahrom
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, Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Nasimi
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Allied Health, Motahari Street, Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
Email
Nasimif@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Nasimi
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Allied Health, Motahari Street, Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
Email
Nasimif@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Nasimi
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Allied Health, Motahari Street, Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
Email
Nasimif@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)