This study aimed to determine the effect of swaddling on weight gain in premature infants between 32 to 37 weeks gestational age and weighing 1000 to 2500 g, and aging more than 72 hours, hospitalized in the neonatal intensive care unit. This study is a clinical trial and quasi-experimental study. The sample size for each group is considered 30. Samples will be selected by simple sampling and randomly placed in two groups. According to the study conditions samples will be matched and then placed in order one in case and next in control group. Neonates in case group during 5 days of hospitalization will be swaddled 5 times a day and each time for 30 minutes by researcher with cotton cloth in Frog Flexible way. Samples in control group will receive routine care.The infant will be excluded if his parents at any time and for any reason want so or there is physiological instability. The weigh of neonates in both groups will be measured and recorded in the morning without any clothing and before feeding, by the responsible nurse of each neonate with seca digital scale. The rate of weight gain between two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022726785N1
Registration date:2016-05-13, 1395/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Teni Hatamian Tirkordi
Name of organization / entity
The International Branch of Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 9020
Email address
hatamian.t@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
researcher
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comapairing the Weight gaining of Two Groups of Swaddled and not Swaddled Premature Infants Hospitalized in Neonatal Intensive Care Unit
Public title
The Effect of Swaddling on Weight gaining of Premature Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Premature infants with gestational age of 32 to 37 weeks; Weight of 1000 to 2500 grams at the start of study; Infant age more than 72 hours; Normal physiologic parameters; Infants with no severe cardio_respiratory, sepsis, metabolic diseases and any indication for surgery.
Exclusion criteria: At any time if parents want to exit their baby from study; Infants who are not stable.
Age
From 3 days old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The International Branch of Behesti University of Medical Sciences
Street address
No 19, Tavanir Street, Valieasr Street.
City
Tehran
Postal code
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
IR.SBMU.IASB.REC
Health conditions studied
1
Description of health condition studied
premature 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. Prematurity NOS
Primary outcomes
1
Description
weight
Timepoint
first day of study before intervention and then daily for 5 days
Method of measurement
Seca digital scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: swaddling the infants with cotton cloth, 5 times daily and each time for 30 minutes in 5 continuous days.
Category
Other
2
Description
Control Group: Routine cares in neonatal intensive care unites
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Teni Hatamian Tirkordi
Street address
Mofid Hospital, Shariyati street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Beheshti University of Medical Siences