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Effect of two methods of Light Reduction on Preterm Infants’ Sleepin the NICU: Randomized Control Clinical Trial

Protocol summary

Summary
The purpose of this study was to determine Effect of two methods of Light Reduction in the sleep rate of premature infants in the NICU, a randomized Control clinical trial. After obtaining informed consent from parents, 60 eligible preterm infants randomly were assigned to the intervention and control groups. Routine light reduction including turn off the lights and draw the curtains of the windows will run from 19 to 7 am was administrated. In the intervention group after decreased routine light, baby incubator covered with thick cover and infant face covered with thin cover. In the control group, addition to routine light reduction, only incubator newborn covered with thin cover, but baby face not covered with anything. One of researcher recorded the infants’ activities such as baby position, oxygen intake, sleeping, waking, cry and eating on a sleep diagram, once a first day and again after the 4 day of both groups by watching the 24 hours video- taped by first camera. A sleep diagram is a column to record 24 hours activities such as sleeping, waking, or feeding, or crying, and the length which is used in 20-minute intervals. Data such as gestational age, birth weight, sex, clinical diagnosis, HR, oxygen rate, type of nutrition and its volume these subjects were obtained from the clinical charts of the hospital , infants' environment light by using a lux meter and sound level by the level meter by coworker measured daily.

General information

Acronym
Effect of Light Rate Reduction on Preterm Infants’ Sleep
IRCT registration information
IRCT registration number: IRCT201409114613N13
Registration date: 2015-01-08, 1393/10/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-28, 1393/10/07
Expected recruitment end date
2015-04-25, 1394/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of two methods of Light Reduction on Preterm Infants’ Sleepin the NICU: Randomized Control Clinical Trial
Public title
Effect of two methods of Light Reduction on Preterm Infants’ Sleep
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 32-28 weeks gestational age preterm infants with congenital hypothyroidism and congenital brain؛ does not have a vision problem؛ taking medications affecting sleep؛ not receiving mechanical ventilation؛ not phototherapy؛ the lack of painful procedures on newborn infants for at least an hour before the measure sleep. Exclusion criteria: baby requiring Phototherapy ؛ mechanical ventilation ؛ intraventricular hemorrhage؛ necrotizing enterocolitis؛ patent ductus arteriosus؛ a blood culture positive sepsis؛ acute lung disease
Age
From 7 days old to 8 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
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
Deputy of Research, Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences
City
tabriz
Postal code
Approval date
2014-11-24, 1393/09/03
Ethics committee reference number
93129

Health conditions studied

1

Description of health condition studied
Preterm Infants’ Sleep
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified

Primary outcomes

1

Description
Preterm Infants’ Sleep
Timepoint
First and fifth study during 24 hours
Method of measurement
sleep diagram

Secondary outcomes

1

Description
Light rate
Timepoint
First birthday, fifth birthday, and after the intervention
Method of measurement
Luxmeter device, Model Light Meter YK-10LX

2

Description
Sector and the incubator volume system by Sound Level Meter
Timepoint
for four days , twice per day: 6pm and 4am
Method of measurement
Sound Level Meter device, Model EXTECH401027

Intervention groups

1

Description
After obtaining informed consent from parents, 60 eligible preterm infants randomly were assigned to the intervention and control groups. In the intervention group, in addition to routine light unit, baby incubator, covered with thick cover and infant face, covered with thin cover.
Category
Other

2

Description
After obtaining informed consent from parents, 60 eligible preterm infants randomly were assigned to the intervention and control groups. In the control group, in addition to routine light unit, baby incubator, covered with thin cover and infant face, will not be covered.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farinaz Saeidi
Street address
Al-Zahra Hospital, Artesh Hospital, Baghshmal Crossroads, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
The Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences (TUOMS).
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Position
Associate Professor /PhD in Nursing
Other areas of specialty/work
Street address
Nursing And Midwifery Faculty , Tabriz University of Medical Sciences T
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
valizades@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

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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