Comparison survey between breast feeding and Sucrose on pain relief and physiological parameters during capillary sampling in neonates: A randomized controlled trial
Objective: The aim of this study is to compare effects of breast feeding and sucrose in reducing pain during minimally invasive procedures in neonates such as capillary sampling. Design: Ninety-five consecutive infants who refer to Razavi Hospital, Mashhad for routine neonates screening will be selected. Participants: Ninety-five consecutive infants who underwent capillary sampling due to neonatal screening. Written informed consent should be filled by both parents. All the infants should meet inclusion criteria such as born at gestational age of ≥37 weeks; aged between 1-5 days and 5 minutes APGAR score of more than 7. Setting and interventions: Newborn infants will be divided to three groups: Group A: 2 ml sterile water as placebo; Group B: 2 ml sucrose 25% and Group C: breast feeding in kangaroo care. ). Main outcome measures: Physiologic parameters including heart rate, blood pressure and capillary oxygen saturation level will be recorded during the sampling and 3 minutes after the procedure. NIPS score as well as physiologic values will be recorded by the investigator in each minute. Final result of NIPS score and physiologic values are the mean of given data for each 1-minute observation. Analysis will be done by means of SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101919589N1
Registration date:2014-12-12, 1393/09/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-12, 1393/09/21
Registrant information
Name
Emadodin Darchini-Maragheh
Name of organization / entity
Mashhad University of Medical Sciences, Mashhad, Iran
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 6692
Email address
darchinime861@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad university of medical sciences, Mashhad, Iran
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison survey between breast feeding and Sucrose on pain relief and physiological parameters during capillary sampling in neonates: A randomized controlled trial
Public title
Effect of breast feeding and Sucrose on pain relief in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: filling the written informed consent by both parents; born at gestational age of ≥37 weeks; aged >24 hours (between 1-5 days); has 5 minutes APGAR score of ≥ 7
Exclusion criteria: Medically instable infants; those who had received sedatives or analgesics in the past 48 hours; infants who had received naloxone in the previous 24 hours; preterm and Low Birth Weight (LBW) infants; Those who had been fed in the past 30 minutes
Age
From 1 day old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee, central building of Mashhad University of Medical Sciences (Ghorshi building), Daneshgah avenue, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
938052
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
pain, not elsewhere classified
Primary outcomes
1
Description
heart rate
Timepoint
each minute until 3 minutes after sampling
Method of measurement
cardiac monitoring
2
Description
blood pressure
Timepoint
each minute until 3 minutes after sampling
Method of measurement
cardiac monitoring
3
Description
capillary oxygen saturation level
Timepoint
each minute until 3 minutes after sampling
Method of measurement
cardiac monitoring
4
Description
pain alleviating
Timepoint
each minute until 3 minutes after sampling
Method of measurement
neonatal infants pain scale score (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
2 ml of sterile water as placebo will be prepared and syringed in anterior part of the tongue 2 minutes before sampling
Category
Placebo
2
Description
2 ml sucrose 25% will be prepared in advance and syringed in anterior part of tongue 2 minutes before sampling
Category
Treatment - Other
3
Description
Infants will be breastfed in kangaroo care. Breastfeeding will be started 2 minutes before sampling and continue during the sampling. Infants are dressed, thus there is no skin to skin contact with mother. Mothers are not allowed to speak with their babies nor swaddle them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razavi Hospital, NICU
Full name of responsible person
Dr. Anahita Alizadeh-Ghamsari
Street address
Azadi square, Ferdowsi university campus, medical university research center
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research- Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Dr. Tafaghodi
Street address
Research Department (Ghoreyshi building) - 2nd floor - Daneshgah Avenue
City
Mashhad
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- Mashhad University of Medical Sciences, Mashhad, Iran
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
Ferdowsi university campus, College of medicine
Full name of responsible person
Emadodin Darchini-Maragheh
Position
Medical student
Other areas of specialty/work
Street address
Medical Toxicology Research Centerو Ferdowsi university campus, Azadi square
City
Mashhad
Postal code
Phone
+98 51 3800 2463
Fax
Email
darchinime861@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical toxicology research center, Imam Reza hospital, Imam Reza square, Mashhad
Full name of responsible person
Dr Anahita Alizadeh-Ghamsari
Position
MD, Pediatrician, fellowship of medical toxicology
Other areas of specialty/work
Street address
Imam Reza Hospital, Medical Toxicology Research Center (MTRC)
City
Mashhad
Postal code
Phone
+98 51 3880 2463
Fax
Email
alizadehan@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Emadodin Darchini-Maragheh
Position
medical student
Other areas of specialty/work
Street address
Medical toxicology research centerو Ferdowsi university campus, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3800 2463
Fax
Email
darchinime861@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)