Evaluation of the relationship between isolation from NCPAP at 3 and 5 cm H2O pressures with the incidence of BPD in neonates admitted to the NICU ward with a gestational age less than or equal to 32 weeks and birth weight less than or equal to 1500 grams.
Investigating the relationship between the isolation of NCPAP at 3 and 5 cm H2O pressure with the incidence of BPD in infants admitted to the NICU department with less than 32 weeks and less or equal birth weight of 1500 grams.
Design
This study is a one-blind clinical trial with parallel groups and randomized sampling using dual randomized blocks on 206 patients.
Settings and conduct
All premature infants with gestational age less than or equal to 32 weeks and birth weight less than or equal to 1500 grams in Shahid Beheshti and Al-Zahra hospitals after receiving the code of ethics if they have inclusion criteria and after obtaining written consent from
Parenting and confirmation by the neonatal specialist are included in the study and connected to the NCPAP device, and in case of stable clinical condition, the process of isolation from NCPAP begins.
Participants/Inclusion and exclusion criteria
-Inclusion criteria
All premature infants with gestational age less or equal than 32 weeks and less or equal birth weight of 1500 grams and Apgar score more than 4 in 5 minutes of birth, which received NCPAP recipient for at least 24 hours immediately after birth with RDS.
-Exclusion criteria:
CHD,
IVH,
Need surgery,
Major anomalies,
Need to be sent to other medical centers,
Receive NCPAP in less than 24 hours,
Apgar score less than 4 in 5 minutes of birth,
Asphyxia,
Craniofacial abnormalities.
Intervention groups
The study groups based on the method of isolation from NCPAP include the isolation group from NCPAP by Sudden Stopping method (SS group) and the isolation group by Gradual Pressure method (GP group).
Main outcome variables
Reducing the incidence of BPD and its complications in premature infants and reducing the costs imposed on the health system and infants' families.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120614010026N11
Registration date:2022-03-13, 1400/12/22
Registration timing:registered_while_recruiting
Last update:2022-03-13, 1400/12/22
Update count:0
Registration date
2022-03-13, 1400/12/22
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between isolation from NCPAP at 3 and 5 cm H2O pressures with the incidence of BPD in neonates admitted to the NICU ward with a gestational age less than or equal to 32 weeks and birth weight less than or equal to 1500 grams.
Public title
Evaluation of the relationship between NCPAP use and chronic lung disease in preterm infants.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All preterm infants less than or equal to 32 weeks of gestation and weighing less than or equal to 1500 g receiving NCPAP for at least 24 hours immediately after birth with a diagnosis of RDS.
Exclusion criteria:
Congenital heart disease,
Third and fourth degree intraventricular hemorrhage,
Need surgery
Major anomalies
Need to be sent to other medical centers
Receive NCPAP in less than 24 hours
Apgar score less than 4 in 5 minutes of birth
Asphyxia,
Having Craniofacial abnormalities
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
206
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done by Randomized by assignment method using double-blind randomized blocks, as one of the groups called A and the other B is named. The order of group A or B is an AB or BA method, and a block is formed for both eligible infants that are admitted to the NICU section. Then, based on the mother's family name and random numbers in numbers, 0 4 arrangements AB and numbers 5 9 BA arranged to reach the sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, parents of neonates (participants) are blind to their baby than the type of respiratory intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-01-06, 1400/10/16
Ethics committee reference number
IR.MUI.MED.REC.1400.731
Health conditions studied
1
Description of health condition studied
Bronchopulmonary dysplasia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rate of Bronchopulmonary Dysplasia
Timepoint
28th birthday
Method of measurement
daily recorded sheet
Secondary outcomes
1
Description
Frequency distribution of pneumothorax
Timepoint
At the time of discharge from the hospital
Method of measurement
Using a questionnaire and daily recorded sheet
2
Description
Frequency distribution of intraventricular hemorrhage(IVH)
Timepoint
At the time of discharge from the hospital
Method of measurement
Using brain ultrasound
3
Description
Frequency distribution of Patent ductus arteriosus (PDA)
Timepoint
At the time of discharge from the hospital
Method of measurement
Using echocardiography
4
Description
Duration of oxygen dependence
Timepoint
At the time of discharge from the hospital
Method of measurement
Using a questionnaire and daily recorded sheet
5
Description
Time to reach full enteral nutrition
Timepoint
At the time of discharge from the hospital
Method of measurement
Using a questionnaire and daily recorded sheet
6
Description
Duration of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
Using a questionnaire and daily recorded sheet
Intervention groups
1
Description
In infants in the intervention group who are under CPAP (Continuous Positive Airway Pressure) if the clinical condition is stable at 5CmH2O, the CPAP pressure is reduced by one every 12 hours to 3CmH2O and then the infant is removed from the device and if necessary , Receive oxygen supplementation with hood with flow of 10 Lit / min. If SPO2 is tolerated and maintained between 91-95% in room air for at least four hours, no oxygen supplementation is required.
Category
Treatment - Devices
2
Description
Infants in the control group under CPAP (Continuous Positive Airway Pressure) are isolated from the device if they have stable clinical conditions at 5CmH2O pressure and, if necessary, receive supplemental oxygen by oxyhood method with a flow rate of 10 Lit / min. If SPO2 is tolerated and maintained between 95-91% in room air for at least 4 hours, no oxygen supplementation is required.