Protocol summary
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Study aim
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Determining the effect of intermediate dose of oral Erythromycin on treating feeding intolerance in preterm neonates
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Design
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In this research 84 preterm neonates with inclusion criteria admitted in Alzahra and Beheshti hospitals are selected. Neonates were randomly divided in to two groups based on numbering syringes of Erythromycin and placebo. neonates are receiving 20 cc/kg/ day feeding and if they tolerate it, 20 cc/kg/day feeding is added every day to receive to 150 cc/ kg/ day. neonates are randomly divided in to two groups. The first group is receiving 20 mg/kg/day erythromycin for 8 days every 6 hours and control group is receiving distilled water, respectively. The principal investigator, blinded to the syringes’ content, was responsible for patient selection and allocated the infants to the interventions in sequence of being entered into the study and based on the table of random numbers
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Settings and conduct
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Alzahra and Shahid beheshti hospitals
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Participants/Inclusion and exclusion criteria
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Preterm infants weighing less than 1800 g who have had frequent milk intolerance without any signs of infection or serious anomalies
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Intervention groups
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neonates are receiving 20 cc/kg/ day feeding and if they tolerate it, 20 cc/kg/day feeding is added every day to receive to 150 cc/ kg/ day. neonates are randomly divided in to two groups. The first group is receiving 20 mg/kg/day erythromycin for 8 days every 6 hours and control group is receiving distilled water, respectively
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Main outcome variables
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time duration to receive to 75. 110, 150 cc/kg/ day feeding volume
General information
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Reason for update
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Acronym
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erythromycin
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IRCT registration information
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IRCT registration number:
IRCT20120614010026N10
Registration date:
2018-01-14, 1396/10/24
Registration timing:
retrospective
Last update:
2018-01-14, 1396/10/24
Update count:
1
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Registration date
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2018-01-14, 1396/10/24
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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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Isfahan university of medical science
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Expected recruitment start date
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2016-03-20, 1395/01/01
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Expected recruitment end date
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2017-09-21, 1396/06/30
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Actual recruitment start date
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2016-03-20, 1395/01/01
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Actual recruitment end date
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2017-09-21, 1396/06/30
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of intermediate dose of oral Erythromycin on feeding intolerance in premature infants
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Public title
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The effect of Erythromycin on feeding intolerance in premature infants
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
premature infants
weight lower than 1800 grams
feeding volume less than 75 cc/kg/ day in the 14th day after birth
frequent lavage (i.e. => 2 times lavage; >50% of milk volume)
parents willingness
Exclusion criteria:
presence of sepsis
gastrointestinal anomalies
cyanotic heart disease
history of operation on gastrointestinal system in the first 14 days after birth
consumption of medication effective in erythromycin metabolism in the same time
incidence of arrhythmia or prolonged QT interval
parents unwillingness
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Age
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From 14 days old to 1 month old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
84
Actual sample size reached:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Table of random numbers
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The syringes of Erythromycin and distilled water are similar in appearance, color and cover. A trained nurse who is not participated in this study, numbered syringes and give them to this study colleague. The colleague divided these syringes among neonates without knowing a bout content of syringe
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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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Ethics committees
1
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Ethics committee
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Approval date
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2016-09-22, 1395/07/01
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Ethics committee reference number
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IR.MUI.REC.1395.3.994
Health conditions studied
1
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Description of health condition studied
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feeding intolerance
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ICD-10 code
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p92.3
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ICD-10 code description
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Underfeeding of newborn
Primary outcomes
1
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Description
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time duration to reach to 75, 110 and 150 cc/kg/ day feeding volume
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Timepoint
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daily, during intervention
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Method of measurement
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observation
Secondary outcomes
1
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Description
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time duration of oxygen dependency
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Timepoint
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during intervention
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Method of measurement
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observation
2
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Description
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time duration of hospitalization
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Timepoint
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during intervention
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Method of measurement
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observation
3
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Description
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sepsis incidence
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Timepoint
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during intervention
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Method of measurement
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physical examination
4
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Description
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necrotizing enterocolitis incidence
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Timepoint
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during intervention
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Method of measurement
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physical examination
Intervention groups
1
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Description
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in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days
in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days
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Category
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Treatment - Drugs
2
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Description
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Control group: distilled water equal volume of erythromycin for 8 days
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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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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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Esfahan 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable