Effect of prophylactic Caffeine on the need for oxygen duration and respiratory support in preterm neonates with weight 1250-2000 gr with RDS requiring nasal CPAP
In our study the effect of caffeine on the need for oxygen duration and respiratory support in preterm neonate with weight 1250-2000 gr with RDS requiring nasal CPAP will be investigated in two groups of caffeine given (group C) and control (group P).
Design
This study is a single blinded interventional randomized controlled clinical trial phase3 with 2 parallel groups (45 patients in each group). A Sequentially numbered computerized randomization with sealed opaque envelopes will be used for randomization.
Settings and conduct
The study sample consisted of infants with spontaneous breathing and clinical signs and symptoms of RDS, and requiring nasal CPAP admitted to the Neonatal intensive care unit (NICU) at Alzahra and Shahid Beheshti hospitals in Isfahan- Iran. After considering the inclusion and exclusion criteria, the neonate, randomized to caffeine (group C) and control (group P). In the caffeine group (C), caffeine will start on the 1st day of life and will continue until discontinuation of CPAP and oxygen administration. In control group, no caffeine or placebo will use.
Participants/Inclusion and exclusion criteria
The inclusion criteria included newborns with a gestational age less than 36 weeks and 6 days; newborns with spontaneous breathing and clinical signs and symptoms of RDS and requiring nasal CPAP.
The exclusion criteria are infants who have major congenital anomalies; asphyxia; occurrence of apnea and need to mechanical ventilation in first 24 hours of birth; congenital cyanotic heart disease and sepsis in the first seven days of birth
Intervention groups
In the caffeine given group (C), 20 mg/kg caffeine as loading dose was begun then each day, 10 mg/kg as maintenance dose was used until discontinuation of CPAP and oxygen administration. In control group, no caffeine was used.
Main outcome variables
The duration of respiratory support with oxygen and CPAP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170627034782N2
Registration date:2019-12-12, 1398/09/21
Registration timing:registered_while_recruiting
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Ramin Iranpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3386 8247
Email address
iranpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic Caffeine on the need for oxygen duration and respiratory support in preterm neonates with weight 1250-2000 gr with RDS requiring nasal CPAP
Public title
Effect of prophylactic Caffeine on duration of respiratory support in preterm neonates with RDS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newborns with a gestational age less than 36 weeks and 6 days
Birth weight between 1250 and 2000 gram
Spontaneous breathing and clinical signs and symptoms of RDS
Requiring nasal CPAP
Exclusion criteria:
Major congenital anomalies
Asphyxia
Occurrence of apnea and need to mechanical ventilation in first 24 hours of birth
Congenital cyanotic heart disease
Sepsis in the first seven days of birth
Only neonates who participate in the study do not know how to prescribe medicine
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National committee for Ethics in Biomedical Research
Street address
Research deputy, Isfahan University of Medical Sciences, Hezarjerib Blvd
City
Isfahan
Province
Isfehan
Postal code
8184757851
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.355
Health conditions studied
1
Description of health condition studied
neonatal respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Duration of respiratory support with nasal CPAP
Timepoint
Hourly, since birth till discontinuation of nasal CPAP
Method of measurement
Report in special charts of neonatal intensive care unit every hour
Secondary outcomes
1
Description
Apnea of prematurity
Timepoint
Hourly, since birth till discharge
Method of measurement
Cardio-respiratory monitoring in daily recorded sheet
2
Description
Duration of oxygen need
Timepoint
Hourly, since birth till discharge
Method of measurement
Daily recorded sheet
3
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Daily recorded sheet
4
Description
Patent ductus arteriosus
Timepoint
Daily
Method of measurement
Cardiac exam and echocardiography if necessary
5
Description
Chronic lung disease
Timepoint
Daily
Method of measurement
Physical exam and chest-xray
6
Description
Pneumothorax
Timepoint
Hourly, since birth till discharge
Method of measurement
Physical exam and chest-xray
7
Description
Nosocomial infection
Timepoint
Daily
Method of measurement
Blood culture
8
Description
Seizure
Timepoint
Daily
Method of measurement
Daily recorded sheet
9
Description
Time to full enteral feed
Timepoint
Daily
Method of measurement
Daily recorded sheet
10
Description
Intraventricular hemorrhage
Timepoint
Third day of life
Method of measurement
Brain sonography
11
Description
Necrotizing enterocolitis
Timepoint
Daily
Method of measurement
Physical exam and abdominal-xray
Intervention groups
1
Description
Intervention group: In the caffeine given group (C), the premature neonate with a weight between 1250-2000 germ and spontaneous breathing with clinical signs and symptoms of RDS and requiring nasal CPAP, 20 mg/kg caffeine as loading dose will be begun (parenteral) and then each day, 10 mg/kg as maintenance dose will be used until discontinuation of CPAP and oxygen administration .
Category
Treatment - Drugs
2
Description
Control group:In control group (P), the premature neonate with a weight between 1250-2000 germ and spontaneous breathing with clinical signs and symptoms of RDS and requiring nasal CPAP no caffeine or placebo was used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital, Isfahan
Full name of responsible person
Ramin Iranpour
Street address
No.16, Sout Resalat St., Mardavij Ave.
City
Isfahan
Province
Isfehan
Postal code
8168967893
Phone
+98 31 3668 1555
Email
iranpour@med.mui.ac.ir
Web page address
https://mui.ac.ir
2
Recruitment center
Name of recruitment center
Beheshti Hospital, Isfahan
Full name of responsible person
Ramin Iranpour
Street address
No.16, Sout Resalat St., Mardavij Ave.
City
Isfahan
Province
Isfehan
Postal code
8168967893
Phone
+98 31 3668 1555
Email
iranpour@med.mui.ac.ir
Web page address
https://mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bahram Nasr esfahani
Street address
Hezrjerib Ave,Isfahan University of Medical Sciences, Isfahan Medical faculty
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 9096
Fax
+98 31 3668 8597
Email
finance@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Iranpour
Position
Associate professor of Pediatrics in Isfahan medical faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 16, Sout Resalat St, Mardavij Ave
City
Isfahan
Province
Isfehan
Postal code
8168967893
Phone
+98 31 3668 1555
Email
ramin.iranpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Iranpour
Position
Associate professor of Pediatrics in Isfahan Medical Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 16, Sout Resalat St, Mardavij Ave
City
Isfahan
Province
Isfehan
Postal code
8168967893
Phone
+98 31 3668 1555
Email
ramin.iranpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Iranpour
Position
Associate professor of Pediaitrics in Isfahan Medical Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 16, Sout Resalat St, Mardavij Ave
City
Isfahan
Province
Isfehan
Postal code
8168967893
Phone
+98 31 3668 1555
Email
ramin.iranpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available