This article aims to find whether or not changing pressure levels without coordination with respiratory cycles affect brain perfusion in preterm neonates’ brain. Newborns weighing less than 1500 gr, hospitalized at Isfahan Beheshti Hospital, who realized the inclusion criteria (Continuous Positive Pressure equal to 4 cm H2O and Fractional Inhaled Oxygen equal to 30%) at 72 hours from birth entered the study. The exclusion criteria included the occurence of prenatal asphyxia, air leak, PDA, and GM-IVH with grades III or IV. This study is done as a crossover randomized clinical trial on 32 newborns. The sampling started in Isfahan Beheshti Hospital from June, 2015, and continued to May, 2016. In this study, the newborns are switched from the non-invasive respiratory management system with one stable pressure level (Control group) to the non-invasive respiratory management system with varied pressure levels (Intervention group) every two hours. In order to conduct the study, using Near Infra-Red Spectroscopy, the newborns' frontal oxygen saturation is monitored every two hours in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123110430N7
Registration date:2016-05-10, 1395/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Alireza Sadeghnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 1777
Email address
sadeghnia@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of NIPPV and nCPAP on Brain Tissue Regional Oximetry in Preterm Neonates Weighing less than 1500 gr with RDS
Public title
The comparison of the effect of NIPPV and nCPAP on Brain Tissue Oxygen content in Preterm Neonates Weighing less than 1500 gr with Respiratory Distress Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
preterm infants weighing less than 1500 gr who had been put under nCPAP respiratory support within 72 hours from birth due to RDS, and also received their first surfactant administration during the first two hours; RDS symptoms such as tachypnea, intercostal retraction, nasal flaring, grunting, and radiography suggestive of RDS; Survanta administration to achieve FiO2≥30% and CDP≥5 cm H2O in order to maintain SpO2 in the range of 89-95% in the right hand; IF at 72 hours from birth, newborns were under nCPAP respiratory support, and if in order to maintain SpO2 in the range of 89-95% in the right hand, CDP was in the range of 4 to 6 cm H2O, with FiO2 at 30% to 40%.
EXCLUSION CRITERIA:
Prenatal Asphyxia (5 min Apgar between 0 to 3, umbilical cord pH less than 7, and umbilical cord Bicarbonate less than 12mEq/L), and congenital disorders; newborns whose first dose of surfactant was administered later than 2 hours from birth; newborns who did not receive surfactant; newborns whose echocardigraphy revealed PDA symptoms; newborns who are under inotrope drugs administration; newborns whose cranial sonography suggested grade III to IV GM-IVH; newborns with air leak symptoms
Age
From 3 days old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Faculty of Medicine, Isfahan University of MEdical Sciences
City
Isfahan
Postal code
Approval date
2015-01-20, 1393/10/30
Ethics committee reference number
394420
Health conditions studied
1
Description of health condition studied
studying the brain tissue oxymetry
ICD-10 code
P52.2
ICD-10 code description
Intraventricular (nontraumatic) haemorrhage, grade 3, of fetus and newborn
Primary outcomes
1
Description
brain tissue oxygenation
Timepoint
third day, seventh day, fourteenth day.
Method of measurement
Near Infrared Spectroscopy
Secondary outcomes
1
Description
intraventicular hemorrhage
Timepoint
daily
Method of measurement
transcranial sonography
Intervention groups
1
Description
Control Group:
In this group, neonates are treated with nCPAP for two hours with two-hour intervals
Category
Treatment - Other
2
Description
Intervention Group:
In this group, neonates are treated with NIPPV for two hours with two-hour intervals
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Marzieh Zamani
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences-Vice chancellery of Research and Technology
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences-Vice chancellery of Research and Technology
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Sadeghnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3335 1777
Fax
Email
asadeghnia@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Sadeghnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3335 1777
Fax
Email
asadeghnia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Sadeghnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3335 1777
Fax
Email
asadeghnia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)