The aim of this study is to determine the effect of Kangaroo Mother Care on serum bilirubin levels in full term newborns with hyperbilirubinemia admitted for photo-therapy.
This study is a clinical trial which 106 infants select randomly in the intervention and control groups with inclusion criteria: (2500 to 4000 grams birth weight ...) and exclusion criteria: (Baby’s hyperbilirubinemia results from breastfeeding ...). Standard method is used to photo-therapy, involving the use of a 4 lamps photo-therapy with blue lights for each incubator, range light is 420 to 480 nano-meters and the distance from the baby is 35 to 40 centimeters. In the experimental group, a baby who is under photo-therapy, get intermittently out of the photo-therapy and is handed over to the mother. The mother, who is wearing kangaroo care dress, puts the naked baby between her breasts, wearing only a diaper. The mother feeds the baby with her milk during hospitalization at least 6 times in the morning, evening and night shifts. Babies in the control group don't receive kangaroo care during the photo-therapy. Primary Outcome: Infants serum bilirubin levels (Before the intervention, 24, 48 and 72 hours after photo-therapy) Secondary outcomes: The infants' photo-therapy (Beginning and end of photo-therapy) and length of stay in hospital (From the time of admission until discharge from the neonatal unit).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505231760N40
Registration date:2015-05-30, 1394/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2015-01-07, 1393/10/17
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kangaroo Mother Care (KMC) on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy
Public title
The effect of Kangaroo Mother Care (KMC) on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weight is 2500 - 4000 grams; Gestational age at birth is 37 - 42 weeks; Apgar score is more than 7 from the first to fifth minutes; All newborns are hospitalized by recognizing the jaundice (from the end of second day to seventh day, diagnosed by a pediatrician); All infants are breastfed; No baby receives medication to reduce bilirubin; No exchange transfusion is performed on neonates; Both parents are Iranian; No baby is dehydrated; Neonate's age is more than 48 hours; Bilirubin level is 15 to 20 mg/dl.
Exclusion criteria:
Neonates suffer from congenital anomaly, respiratory failure and known infection; Infants have jaundice on the first day of birth; Baby’s hyperbilirubinemia results from breastfeeding; There are some signs of sepsis in neonates; Newborn suffers from cephalohematoma, purpura and petechia; There is a history of anemia or hyperbilirubinemia for his/her mother, father, sister or brother; Apgar score from first to fifth minute is less than 7; Neonate has umbilical artery catheter or chest tube; There is Rh incompatibility between mother and infant; Hyperbilirubinemia is owing to G6PD deficiency; Infant needs the exchange transfusion; Mother is not willing to cooperate during the study; Baby has intraventricular hemorrhage; Mother suffers from HBSAg+; Neonate is suspected to have TORCH.
Age
From 3 days old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The intervention and control groups in terms of the characteristics of age, bilirubin and integration are ABO incompatibility.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2015-01-06, 1393/10/16
Ethics committee reference number
5032
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Neonatal serum bilirubin level
Timepoint
Before intervention, 24, 48 and 72 hours after intervention
Method of measurement
Laboratory
Secondary outcomes
1
Description
Duration of hospitalization in neonatal unit
Timepoint
Discharge time from neonatal unit
Method of measurement
Clinical
2
Description
Duration of Phototherapy
Timepoint
At the beginning and the end of phototherapy
Method of measurement
Clinical
Intervention groups
1
Description
Intervention groups:
Using kangaroo mother care and photo-therapy.
(KMC is clothing made of cotton. Open from behind and from the front of the pocket is great for putting baby in the hospital haute couture Amirkola be sewn.)
(The four lamp with a blue light photo-therapy device for each Incubator, with a range of 420 to 480 NM light at a distance of 35 to 40 cm of the baby.
Category
Treatment - Other
2
Description
Control groups:
Using only photo-therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Hospital of Pediatrics
Full name of responsible person
Nasrin Rasuli Larma'i
Street address
Amirkola, Pediatrics Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
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 and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Nasrin Rasuli Larma'i
Position
Master Student of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3225 0691
Fax
Email
n.rasuli@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical sciences
Full name of responsible person
Dr Mousa Ahmadpour
Position
Neonatal specialist
Other areas of specialty/work
Street address
Amirkola, Pediatrics Hospital Babol
City
Babol
Postal code
Phone
+98 11 3234 2151
Fax
Email
m.ahmadpour@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)