Protocol summary
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Study aim
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Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature neonates
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Design
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The clinical trial with parallel groups, one blind strain, randomized in two groups, phase 2-3 is performed on 80 babies. The rand function of Excel software is used for randomization.
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Settings and conduct
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A single-blind interventional study is conducted on infants hospitalized in the neonatal intensive care unit of Afzalipur Hospital in Kerman, who meet the conditions for entering the study. After the random allocation and receiving the medicine, the babies are examined and the primary and secondary outcomes are checked and recorded.
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Participants/Inclusion and exclusion criteria
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Entry conditions: neonates with a gestational age of less than 35 weeks and hemodynamic stability during the first 48 hours after mechanical ventilation.
Conditions of non-entry: neonates with congenital obstruction and perforation of the gastrointestinal tract, gastroschisis, congenital diaphragmatic hernia, cyanotic heart diseases and other congenital anomalies.
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Intervention groups
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The first group are infants who are treated with caffeine citrate with an initial dose of 20 mg per kilogram of weight per day and a maintenance dose of 10 mg per kilogram of weight per day until the infant does not experience apnea at least 7 days after extubation. are placed (group with high maintenance dose). The second group are infants who receive caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 5 mg per kilogram of body weight per day until the infant does not experience apnea at least 7 days after extubation.
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Main outcome variables
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Tracheal extubation failure and subsequent apnea
General information
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Reason for update
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End of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230408057850N1
Registration date:
2023-04-17, 1402/01/28
Registration timing:
prospective
Last update:
2023-08-01, 1402/05/10
Update count:
1
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Registration date
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2023-04-17, 1402/01/28
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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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Expected recruitment start date
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2023-04-21, 1402/02/01
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Expected recruitment end date
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2023-07-23, 1402/05/01
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Actual recruitment start date
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2023-04-21, 1402/02/01
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Actual recruitment end date
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2023-07-11, 1402/04/20
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Trial completion date
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2023-07-24, 1402/05/02
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Scientific title
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Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants
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Public title
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Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Neonates with a gestational age of less than 35 weeks
Hemodynamic stability during the first 48 hours after mechanical ventilation
Exclusion criteria:
Neonates with congenital obstruction and perforation of the gastrointestinal tract
Gastroschisis
Congenital diaphragmatic hernia
Cyanotic heart diseases
Other congenital anomalies
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Age
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From 1 day old to 28 days old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The rand function of Excel software was used for randomization. Based on the random number obtained in the software, the babies are divided into two groups and this process will continue for each group up to 40 people.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the researcher is informed about the division of groups and the parents have received explanations about the research, but they are not informed about the division of groups. Also, the statistician does not know which data belong to the group with high dose of caffeine.
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Placebo
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Not 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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2023-01-17, 1401/10/27
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Ethics committee reference number
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IR.KMU.AH.REC.1401.247
Health conditions studied
1
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Description of health condition studied
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Tracheal tube extubating and subsequent apnea in premature neonates
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ICD-10 code
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P28.4
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ICD-10 code description
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Other apnea of newborn
Primary outcomes
1
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Description
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Tracheal extubation failure and subsequent apnea
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Timepoint
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During the hospitalization period
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Method of measurement
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Physical examination
Secondary outcomes
1
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Description
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Tachycardia
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Timepoint
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Duration of treatment
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Method of measurement
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Cardiac monitoring
2
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Description
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Nutritional intolerance
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Timepoint
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Duration of treatment
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Method of measurement
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Physical examination
3
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Description
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Apnea of prematurity
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Timepoint
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Before and the end of the intervention
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Method of measurement
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Physical examination
4
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Description
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Duration of use of mechanical ventilation
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Timepoint
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Before and the end of the intervention
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Method of measurement
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Based on the questionnaire and file information
5
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Description
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Hospitalization period
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Timepoint
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Before and the end of the intervention
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Method of measurement
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Based on the questionnaire and file information
6
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Description
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Necrotizing enterocolitis
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Timepoint
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Before and the end of the intervention
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Method of measurement
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Clinical examination and abdominal imaging
7
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Description
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Ductus arteriosus remains open
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Timepoint
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Before and the end of the intervention
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Method of measurement
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Clinical examination and echocardiography
Intervention groups
1
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Description
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Intervention group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 10 mg per kilogram of body weight.
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Category
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Treatment - Drugs
2
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Description
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Control group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 5 mg per kilogram of body weight.
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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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Kerman 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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Undecided - It is not yet known if there will be 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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Yes - There is 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Its release schedule is not yet known
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When the data will become available and for how long
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Its release schedule is not yet known
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To whom data/document is available
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Its release schedule is not yet known
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Under which criteria data/document could be used
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Its release schedule is not yet known
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From where data/document is obtainable
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Its release schedule is not yet known
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What processes are involved for a request to access data/document
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Its release schedule is not yet known
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Comments
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