This study is an experimental study to determine the impact of the planned lighting on the weight gain and length of stay in preterm infants admitted to the neonatal intensive care unit in Mofid children’s Hospital will be done. Inclusion criteria: respiratory distress syndrome or apnea of prematurity; lack of physical abnormalities and exclusion criteria: jaundice, need for surgery; requiring a long period of continuous lighting for treatment interventions; infants who died before discharge. The study population included all preterm infants 30 to 37 weeks with birth weight of 1500 to 2500 admitted to Mofid children’s Hospital. The sample size in this study is 66 preterm infants. From 7 am to 7 pm infants in the intervention group will receive usual light and from 7 pm to 7 Am brightness is reduced by putting dimming cover of light on the head. When intervention group were incubated and did not need respiratory support, in order to avoid disrupting the air flow, the incubator was pulled by cotton cloth. This intervention will maintain until discharge. While at all hours of the day the control group will receive usual light in NICU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073129141N1
Registration date:2016-09-13, 1395/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-13, 1395/06/23
Registrant information
Name
Elahe Aghaziarati Farahani
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services. School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
ela.farahani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of planned lighting on weight gain and length of stay of preterm infants
Public title
Effect of planned lighting on weight gain and length of stay of infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 30–37 weeks’ gestation; Birth weight between 1500-2500; Apgar score equal or more than 7; neonates suffered from respiratory distress syndrome or apnea of prematurity; Lack of life-threatening problem; lack of physical abnormalities. exclusion criteria: jaundice, need for surgery; requiring a long period of continuous lighting for treatment interventions; infants who died before discharge.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
University of Medical Sciences and Health Services Shahid Beheshti
Street address
next Shahid Ayatollah Taleghani Hospital, Arab street, Street Yemen, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
1985717443
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.SBMU.RAM.REC.1394.606
Health conditions studied
1
Description of health condition studied
Preterm infant
ICD-10 code
p07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation
Primary outcomes
1
Description
planned lighting
Timepoint
after intervention
Method of measurement
profile
Secondary outcomes
1
Description
weight gain
Timepoint
Since the infant hospitalization in NICU until discharge
Method of measurement
Baby Weighing Scale
2
Description
length of stay
Timepoint
Since the infant hospitalization in NICU until discharge
Method of measurement
number of days
Intervention groups
1
Description
From 7 am to 7 pm infants in the intervention group will receive usual light and from 7 pm to 7 Am brightness is reduced by putting dimming cover of light on the head. When intervention group were incubated and did not need respiratory support, in order to avoid disrupting the air flow, the incubator was pulled by cotton cloth. This intervention will maintain until discharge
Category
N/A
2
Description
at all hours of the day the control group will receive usual light in NICU.