The survey of the effect of parenteral caffeine citrate for prevention of apnea in very preterm neonates in NICU part of Shahid-Motahary hospital for one year
This study is conducted in preterm infants with a gestational age of 32 weeks and less and birth weight less than 1500 grams in the NICU department of Shahid-Motahari Hospital. Infants are randomly assigned into two groups: Infants of group A on the second day of birth (24-48 h) intravenous caffeine citrate with a dose of 20mg/kg and then the maintenance dose 24 hours after the first injection with a dose of 5mg/kg daily injected. Group B received no caffeine. Infants undergo cardiaco-pulmonary monitoring and control heart rate and respiratory rate, as well as arterial oxygen saturation control. Appendicitis reported by nurses on cyanotic attacks and loss of saturation will be documented (on special charts of the researcher). Given the effectiveness of the birth weight, patients divided into three groups (less than 1000 grams, 1,249,1250-1500) and the weight of the birth is divided into three groups, in order to compare the two groups in terms of the same confounding factors. Newborns in the control group will undergo standard treatment if they develop apnea. In addition, the two groups will not differ in their routine neonatal therapies, such as administration of total parenteral nutrition (TPN) and antibiotics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102637023N1
Registration date:2017-11-14, 1396/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
Zahra Fakoor
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3224 4830
Email address
drfakoor@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the effect of parenteral caffeine citrate for prevention of apnea in very preterm neonates in NICU part of Shahid-Motahary hospital for one year
Public title
Effect of parenteral caffeine citrate for prevention of apnea in very preterm neonates in NICU ward
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for entering were the premature newborns weighing less than 1500 grams at least 24 hours of age and having self-contained breathing in the first 24 hours of life; and exclusion criteria were maternal major anomalies, the incidence of apnea in the first 24 hours of life and the need for mechanical ventilation in 24 The first hour of birth, cyanotic heart disease, small age for gestational age (SGA, IUGR), intrauterine growth retardation, as well as clinical evidence for sepsis during the first 7 days of birth and IVH grade 3 or 4 during the first week of life.
Age
From 1 day old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urjans Street - Head of Urmia University of Medical Sciences
City
Urmia
Postal code
Approval date
2016-12-09, 1395/09/19
Ethics committee reference number
IR.UMSU.REC.1395.360
Health conditions studied
1
Description of health condition studied
Apnoea
ICD-10 code
P28.3
ICD-10 code description
Primary sleep apnoea of newborn
Primary outcomes
1
Description
Apnoea
Timepoint
From beginning to end of intervention
Method of measurement
The number of cases of apnea reported by the nurse
Secondary outcomes
1
Description
Bradicardia
Timepoint
From beginning to end of intervention
Method of measurement
The number of cases of bradicardia reported by the nurse
2
Description
Cyanosis
Timepoint
From beginning to end of intervention
Method of measurement
The number of cases of cyanosis reported by the nurse
3
Description
Duration of oxygen demand
Timepoint
From beginning to end of intervention
Method of measurement
Duration of oxygen demand reported by the nurse
4
Description
Duration of NCPAP demand
Timepoint
From beginning to end of intervention
Method of measurement
Duration of NCPAP demand reported by the nurse
5
Description
Duration of mechanical ventilation demand
Timepoint
From beginning to end of intervention
Method of measurement
Duration of mechanical ventilation demand reported by the nurse
6
Description
hospitalization
Timepoint
From beginning to end of intervention
Method of measurement
Patients' Records
Intervention groups
1
Description
Control received no caffeine.
Category
Placebo
2
Description
Infants of intervention group on the second day of birth (24-48 h) intravenous caffeine citrate with a dose of 20mg/kg and then the maintenance dose 24 hours after the first injection with a dose of 5mg/kg daily injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Shahid-Motaharii Hospital
Full name of responsible person
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Mecidal Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Head of Urmia University of Medical Science, Urjans alley, Pezeshkian Street.
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Mecidal 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
Urmia University of Medical Sciences
Full name of responsible person
Dr Zahra Fakoor
Position
Associate professor of neonates
Other areas of specialty/work
Street address
Shahid-Motaharri Hospotal
City
Urmia
Postal code
Phone
+98 44 3224 4830
Fax
Email
drfakoor@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr Zahra Fakoor
Position
Associate professor of neonates
Other areas of specialty/work
Street address
Shahid-Motaharri Hospital
City
Urmia
Postal code
Phone
+98 44 3224 4830
Fax
Email
drfakoor@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr Zahra Fakoor
Position
Associate professor of neonates
Other areas of specialty/work
Street address
Shahid-Motaharri Hospital
City
Urmia
Postal code
Phone
+98 44 3224 4830
Fax
Email
drfakoor@umsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)