Comparing sudden complete versus gradual weaning from nasal continuous positive airway pressure (NCPAP) in preterm infants
Design
Two arm parallel group randomized singleblind clinical trial
Settings and conduct
Location of study: Isfahan NICU wards.
Blinding method: Single blind, in which parents were kept unaware of the study (intervention) group.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Preterm infants younger than 32 weeks of gestation; 5-minute Apgar score over 4. Exclusion criteria: congenital heart anomalies (except for small atrial septal defect, patent foramen ovale, and patent ductus arteriosus (PDA)); definitely or possibly diagnosed neuromuscular diseases; the need for surgery
Intervention groups
Intervention group: infant is separated from NCPAP and is allowed to breathe in the room air with FiO2 of 21% or with extra oxygen with FiO2 of 40% for 4 hours.
Control group: sudden complete weaning, the infant is separated completely from the set and is allowed to breathe in room air (FiO2 = 21%) or with extra oxygen with FiO2 of maximally 40%.
Main outcome variables
successful NCPAP weaning in the first attempt.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180915041040N1
Registration date:2018-11-30, 1397/09/09
Registration timing:retrospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Roya Choopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
choopani.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-03, 1393/08/12
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
2014-11-03, 1393/08/12
Actual recruitment end date
2015-12-11, 1394/09/20
Trial completion date
2016-08-31, 1395/06/10
Scientific title
Comparing sudden Complete and gradual weaning on successful weaning from nasal CPAP in preterm infants
Public title
weaning from nasal continuous positive airway pressure in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age equal to or less than 32 weeks and birth weight equal to or less than 1800 gr
Starting NCPAP from first hours of birth to treat respiratory distress syndrome
Treatment with NCPAP after weaning from positive pressure ventilation via endotracheal route
The newborn should be under treatment with NCPAP for at least 24 hours
5th minute APGAR score above 4
Exclusion criteria:
Documented congenital heart anomalies (except for small atrial septal defect, patent foramen ovale, and patent ductus arteriosus (PDA))
definite or possible neuromuscular disease
definite or possible syndrome
need for surgery
transfer to other hospital
patients weighing less than 750 g at the time of randomization
intraventricular hemorrhage (grade above 2)
lung hypoplasia
other life-threatening congenital anomalies
thoracic or airway anomalies
need for mechanical ventilation before NCPAP removal
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Using random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind.
Parents of neonates were kept unaware of the groups their neonate was allocate to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib st. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
393348
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
successful NCPAP weaning in the first attempt
Timepoint
After first attempt to NCPAP weaning
Method of measurement
Number of attempts
Secondary outcomes
1
Description
The frequency of weaning
Timepoint
After each time of weaning from the device
Method of measurement
Document
Intervention groups
1
Description
Intervention group: infant is separated from NCPAP and is allowed to breathe in the room air with FiO2 of 21% or with extra oxygen with FiO2 of 40% for 4 hours. Then, NCPAP with 5 cm H2O PEEP and FiO2 of 21% is applied for 6 hours. Under a stable clinical condition over the 6 hours, weaning is performed and the duration of separation is increased every 4 hours up to 12 hours. The duration of NCPAP between weaning intervals will be constant, i.e., 6 hours. In the next step, when the infant is weaned for 12 hours and no criteria of treatment failure is occurred, NCPAP is continued for additional 6 hours and then, the infant is completely weaned.
Category
Treatment - Devices
2
Description
Control group: sudden complete weaning, the infant is separated completely from the set and is allowed to breathe in room air (FiO2 = 21%) or with extra oxygen with FiO2 of maximally 40%
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
NICUs in Isfahan
Full name of responsible person
Roya Choopani
Street address
Beheshti haspital, Motahari st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6340
Email
dr.choopani@yahoo.com
Web page address
http://www.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Hagh joo
Street address
Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7653
Email
dr.choopani@yahoo.com
Web page address
http://www.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
Roya Choopani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tadbir Building, Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7653
Fax
Email
choopani.r@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tadbir Building, Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7653
Fax
Email
choopani.r@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tadbir Building, Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7653
Fax
Email
choopani.r@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD