Comparison of different strategies for stopping positive airway pressure (NCPAP) in premature infants with respiratory distress syndrome.
Design
Clinical trial without control group, community-based and pragmatic, with parallel groups, no blinding, randomized
Settings and conduct
In this study, clinical trials of premature infants 26 to 32 weeks and six days of age with respiratory distress syndrome were born at the Al-Zahra Educational and Medical Center in Tabriz with respiratory scordiosis (ACORN) 5 to 8%.
Participants/Inclusion and exclusion criteria
Exclusion Criteria
1. Infants with chromosomal defects
2. Infants with severe congenital anomalies or severe congenital heart disease
3. Infants with sphincter with Apgar in the fifth minute less than 7
4. Infants under mechanical ventilation
5. Revived (advanced) babies
6. Babies with parental dissatisfaction with entering the study
Intervention groups
The first group underwent positive airway pressure to 5% and oxygen depletion consumption to 30% under respiratory support with HFNC 3_5 liters per minute and oxygen depletion of 30%.
The second group gradually reduced their airway stability (PEEP) by 1 cm every 8 hours, with positive airway pressure reaching 3% and oxygen depletion reaching 25%
The third group, every 8 hours, 1 cm of airway pressure was reduced (PEEP) and with positive pressure, airway was reduced to 3 and oxygen consumption was reduced to 25% in neonatal respiratory support with oxyhoud 5-6 liters per minute and oxygen depletion. Consumption is 30%.
Main outcome variables
Respiratory distress rate and apnea
Requires oxygen consumption
Duration of hospitalization
The incidence of chronic lung disease
Narcissistic retinopathy
Intraventricular hemorrhage
The incidence of sepsis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160102025811N5
Registration date:2021-04-05, 1400/01/16
Registration timing:retrospective
Last update:2021-04-05, 1400/01/16
Update count:0
Registration date
2021-04-05, 1400/01/16
Registrant information
Name
Mirhadi Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
drmussavihadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2020-03-20, 1399/01/01
Scientific title
Investigate various strategies for weaning nasal continuous positive airway pressure (NCPAP) in premature neonates with respiratory distress syndrome
Public title
weaning nasal continuous positive airway pressure (NCPAP) in premature neonates with respiratory distress syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants 26 to 32 weeks and six days with respiratory distress syndrome (premature onset of respiratory distress in the first 4 hours of life or radiographic findings in favor of respiratory distress syndrome) Positive airway pressure has been implicated in neonatal intensive care unit (NICU).
Exclusion criteria:
Infants with chromosomal defects
Infants with severe congenital anomalies or severe congenital heart disease
Infants with sphincter with Apgar less than 7 minutes
Infants under mechanical ventilation
Revived (advanced) babies
Babies with parental dissatisfaction with entering the study
Age
From 104 days old to 224 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, clinical trials of premature infants 26 to 32 weeks and six days of age with respiratory distress syndrome were born at the Al-Zahra Educational and Medical Center in Tabriz with respiratory shockorder (ACORN) 5 to 8%. They were airborne (NCPAP) (after the acute phase of the primary disease and the start of weaning with the approval of neonatal subspecialty or neonatal subspecialty assistant), the study entered and the infants were randomly divided into 3 groups by computer guidance.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Av.Azadi, Av.Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
65423987456
Approval date
2019-03-27, 1398/01/07
Ethics committee reference number
ir.tbzmed.rec.1398.176
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
respiratory distress syndrome score
Timepoint
Prior to intervention in all study groups and daily at specified times until discontinuation of respiratory support
Method of measurement
Score based on the number of breaths, need for oxygen, retraction, moaning, breathing sounds , immaturity
2
Description
Apnea
Timepoint
Before the intervention and at certain times daily after the intervention until the cessation of respiratory support
Method of measurement
Number of respiratory arrests per hour
3
Description
Duration of hospitalization
Timepoint
From the beginning to the end of the patient's hospitalization
Method of measurement
Number of days spent in the hospital
4
Description
Need to oxygen therapy
Timepoint
Before intervention and daily at specified times until discontinuation of respiratory support
Method of measurement
10% increase in fraction of inspired oxygen(yes/no)
5
Description
Retinopathy of Prematurity
Timepoint
At 28 days of birth
Method of measurement
Ophthalmological consultation
6
Description
Intraventricular haemorhage
Timepoint
At the end of intervention
Method of measurement
Brain sonography
7
Description
Respiratory Distress Syndrome
Timepoint
at the end of intervention
Method of measurement
Need oxygen after discharge
8
Description
Mortallity
Timepoint
At the end of intervention
Method of measurement
Neonate death
Secondary outcomes
empty
Intervention groups
1
Description
Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 5 and an fraction of inspired oxygen of 30%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 30%.
Category
Treatment - Devices
2
Description
Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 3 and an fraction of inspired oxygen of 25%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 25%.
Category
Treatment - Devices
3
Description
Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% ,infants will be located in oxygen hood with 5-6 liters per minute and fraction of inspired oxygen 30%.
Category
Treatment - Devices
4
Description
Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% , ventilation support will be cessated and infants will be located in room air.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mirhadi Mousavi
Street address
Sheshgelan street
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
mirhadimousavi33@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Av.Azadi , Av.Golgast
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
mirhadimousavi33@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mirhadi Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3327 2094
Fax
+98 41 3327 2095
Email
drmussavihadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mirhadi Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3327 2094
Fax
+98 41 3327 2095
Email
drmussavihadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mirhadi Mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3327 2094
Fax
+98 41 3327 2095
Email
drmussavihadi@yahoo.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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available