The sleep/wake cycle in newborns with 28 to 32 weeks of gestational age: A Comparative study of Nasal Continuous Positive Airway Pressure (nCPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV)
A comparative study of the effect of nasal Continuous Positive Airway Pressuren (CPAP) and Noninvasive Positive-Pressure Ventilation (NIPPV) on sleep-wake cycle in preterm infants
Design
This is a crossover clinical research with its intervention and control group being interchangeably named.
Sample size calculation will be done using PWR software.
Randomization will not be done.
Settings and conduct
The study will be conducted in the NICU. The sleep-wake cycle of preterm neonates during the recovery phase of RDS under non-invasive respiratory support using amplitude-integrated elctroencephalography (aEEG) in nCPAP and NIPPV interventions will be monitored intermittently.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
preterm neonates who are still under nCPAP support due to Respiratory Distress Syndrome (RDS) followed by surfactant administration with respiratory support indices as follows:
CDP: 4-6 cmH2O; FiO2: 30-40% to maintain SPO2 at 89-95% in the right hand.
Exclusion criteria:
Perinatal asphyxia and congenital anomalies.
Neonates whose first surfactant administration was after 2 hours of birth.
Neonates who did mot receive surfactant administration.
nNeonates showing evidence of Patent Ductus Arteriosus (PDA) in echocardiography.
Neonates under administration of inotropic drugs.
Neonates showing evidence of Germinal Matrix Hemorrhage-Intraventricular Hemorrhage (GM-IVH) grade III or IV in cranial ultrasonography.
Neonates with air leak.
Intervention groups
A group of preterm neonates with RDS underwent two approaches of non-invasive respiratory support (control group) and non-invasive ventilation (intervention group).
Main outcome variables
Comparative investigation of the effect of nCPAP and NIPPV on the number and duration of sleep-wake cycle in neonates
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120728010430N9
Registration date:2020-07-06, 1399/04/16
Registration timing:retrospective
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
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
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2020-04-19, 1399/01/31
Scientific title
The sleep/wake cycle in newborns with 28 to 32 weeks of gestational age: A Comparative study of Nasal Continuous Positive Airway Pressure (nCPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV)
Public title
Effect of Nasal Respiratory Support on the Sleep-wake cycle of Preterm Newborns
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with the gestational age of 28 to 32 weeks still receiving nCPAP support 72 hours after birth whose first surfactant administration was during the first 2 hours after birth
Neonates receiving nCPAP support in order to maintain oxygen saturation (89%-95 at right hand) 72 hours after birth while CDP is at 4-6 cm H20 and FiO2 is at 30%-40%.
Exclusion criteria:
Perinatal Asphyxia (Apgar at fifth minute=0-3, Umbilical cord pH<7, Umbilical cord Bicarbonate < 12 mEq/L), Congenital Malformation
Neonates whose first surfactant administration is 2 hours after birth
Neonates with no surfactant administration
Neonates showing evidence of PDA through Echocardiography
Neonates under administration of Inotrope drugs
Neonates showing evidence of GM-IVH in grades III-IV in cranial sonography
Neonates with air leakage
Age
From 7 months old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Not 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
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Medical Sciences, Isfahan University of Medical Sciences, Isfahan
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.MED.REC.1397.268
Health conditions studied
1
Description of health condition studied
The effect of a restrictive pulmonary disease and relevant medical interventions on Brain Hemodynamics
ICD-10 code
P22.0
ICD-10 code description
Hyaline membrane disease
Primary outcomes
1
Description
The number and duration of sleep-wake cycle
Timepoint
before intervention during a 6-hour period and during a 6-hour interval after intervention
Method of measurement
Using amplitude integrated EEG (Electroencephalography)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Non-invasive ventilation based on one level of pressure during intervention
Category
Diagnosis
2
Description
Intervention group: the neonate receiving non-invasive respiratory support with a specific level of pressure receives non-invasive respiratory support over another period with two different levels of pressure having specific timing
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Alireza Sadeghnia
Street address
Beheshti Obstetrics and Gynecology Hospital - Motahari St., Felezi bridge
City
Isfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
asadeghnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Head of Faculty Research and Technology
Street address
Isfahan University of Medical Sciences, Daneshgah St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@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
Alireza Sadeghnia
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Isfahan University of Medical Sciences, Daneshgah St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
asadeghnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza sadeghnia
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Isfahan University of Medical Sciences, Daneshgah St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
asadeghnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza sadeghnia
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Isfahan University of Medical Sciences, Daneshgah St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
asadeghnia@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some data related to Electrical cortex activity can be shared in aEEG format.
When the data will become available and for how long
The data can be shared from September 2020 until the end of December 2020.
To whom data/document is available
Researchers who aim at conducting research in the field of child health can access the data.
Under which criteria data/document could be used
There are no specific criteria.
From where data/document is obtainable
You can send an e-mail to the corresponding author to access the documents.
What processes are involved for a request to access data/document
An e-mail would suffice. The e-mail address must be an academic one or of a research organization.