Protocol summary
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Study aim
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The purpose of this study is the investigating of prophylactic effect of Manna of Cotoneaster in management of neonatal hyperbilirubinemia. This study was performed on 444 neonate patients, who admitted into the rooming in Imam Khomeini Hospital, Sari, Iran. Informed consent will be obtained from mothers
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Design
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Randomization: using blocking method.
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Settings and conduct
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This study was performed on 444 neonate patients, who admitted into rooming in ward Imam Khomeini Hospital, Sari, Iran. Informed consent will be obtained from mothers.The Blind: To double-blind study, Manna of cotoneaster solution and placebo solution container similar appearance (provided by the laboratory of Sari Pharmacy Faculty) and the user, administer and appraiser of them do not know about it. After administration of cotoneaster, all neonate will assess by one neonatologist.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: All healthy neonate with breastfeeding are examined by doctor and weight is between 2.5 to 4 kg. Exclusion criteria: Babies with a genetic anomaly, Congenital, Intrauterine infection or jaundice within 24 hours of birth and mothers who are not satisfied and want to be excluded
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Intervention groups
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Intervention group:The amount of 1 g of cotoneaster per day is divided into 3 doses for 3 days.
Control group: The neonate will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops.
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Main outcome variables
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The bilirubin concentration measured in 3 sets (24 hours 48 hours and 72 hours after birth) and its number is recorded. The Meconium departure time controlled daily for three days after birth. The baby bilirubin concentration measured through the skin by bilirubin test device. Then on the third day that neonatal follow up examination will be done, bilirubin concentration measured through the skin with the same device.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016060128188N1
Registration date:
2016-10-22, 1395/08/01
Registration timing:
prospective
Last update:
2019-05-02, 1398/02/12
Update count:
3
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Registration date
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2016-10-22, 1395/08/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Mazandaran University of Medical Sciences
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Expected recruitment start date
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2016-12-21, 1395/10/01
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Expected recruitment end date
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2017-11-06, 1396/08/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The investigating of the prophylactic effect of Manna of Cotoneaster in neonatal jaundice
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Public title
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Preventive effect of droplets on infant's jaundice
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Full-term baby (with gestational age 38-42 weeks)
Birth weight 2.5-4 kg
No postpartum complications
Breastfeeding within the hour of birth
Availability of parents for follow-up purposes
PO tolerance by the infant (no nausea, vomiting or obstructive symptoms
The absence of meconium contamination
No need for CPR at birth
No labor trauma
Exclusion criteria:
Genetic and congenital abnormalities or intrauterine infections
Jaundice within the first 24 hours of birth
ABO or Rh incompatibility
Presence of neonatal hemolytic process
Neonates with bleeding and cephalohematoma
Self-administration of Cotoneaster
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Age
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From 1 day old to 14 days old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
444
More than 1 sample in each individual
Number of samples in each individual:
3
Measuring Bilirubin
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using blocking method
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To double-blind study, cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it. Bilirubin drop and placebo drops (drug and placebo ) are provided by the laboratory of Sari Pharmacy Faculty.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Using blocking method
Ethics committees
1
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Ethics committee
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Approval date
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2015-04-08, 1394/01/19
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Ethics committee reference number
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IR.MAZUMS.REC.1394.1316
Health conditions studied
1
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Description of health condition studied
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Neonatal jaundice
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ICD-10 code
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p59.9
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ICD-10 code description
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neonatal jaundice
Primary outcomes
1
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Description
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Added at 2017-06-11: Baby serum total bilirubin
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Timepoint
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Added at 2017-06-11: Every 24 hours for 3 days
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Method of measurement
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Added at 2017-06-11: Using a bilirubin test device (if a bilirubin is high, a bilirubin serum test will be performed based on the weight and age curve)
Secondary outcomes
1
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Description
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Require hospitalization and Length of hospitalization days
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Timepoint
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From discharge to 14 days after birth
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Method of measurement
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Follow up by phone from the baby's parents
2
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Description
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Added at 2017-06-18: Evaluation of side effects in case of Cotoneaster
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Timepoint
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Added at 2017-06-18: Every 24 hours for 3 days
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Method of measurement
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Added at 2017-06-18: Observation and complete check list
Intervention groups
1
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Description
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Intervention group:The amount of 1 g of cotoneaster per day is divided into 3 doses for 3 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: The neonate will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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1394.1316
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All information will be published in an article. Details of the data are available at the request of the journal publisher and upon obtaining permission from the corresponding author.
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When the data will become available and for how long
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Data is available as an article as soon as the article is published with permission from the corresponding author.
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To whom data/document is available
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The data is provided as an article by the journal, and those who have access to the journal can use the data contained in the article, with the permission of the corresponding author.
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Under which criteria data/document could be used
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The article's data is available in case of publication and is obtained by permission from the corresponding author.
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From where data/document is obtainable
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The data is available to the journal and is accessible by obtaining permission from the corresponding author.
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What processes are involved for a request to access data/document
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Data is available from the journal after publication of the article.
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Comments
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