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Efficacy of continuous positive oscillatory nasal airway pressure versus continuous positive nasal airway pressure in neonates with 28-34 weeks of gestational age with respiratory distress syndrome: A randomized controlled trial

Protocol summary

Summary
The aim of this study is to investigate whether Oscillatory NCPAP, in comparison to NCPAP, can reduce the need for intubation and mechanical ventilation in preterm neonates with suspected RDS. In this single center, not blinded and randomized controlled trial, based on a random number table, 128 neonates, at 28-34 gestational weeks, who had respiratory distress syndrome and a Silverman-Anderson retraction Score of 6-7, admitted to Imam Khomeini Hospital's NICU during 2016 (64 in each group) were included. We use Oscillatory NCPAP (cno ncpap driver) with Peak end expiratory pressure (PEEP) of 4-6 cm of water, fraction of inspired oxygen (FiO2) equal to 0.4, frequency of 3 Hz and amplitude of 3 mv and NCPAP (sindi ncpap driver) with Peak end expiratory pressure (PEEP) 4-6 cm of water, fraction of inspired oxygen (FiO2) equal to 0.4. Babies were excluded if there was congenital malformation, severe cardiovascular instability and severe asphyxia or if parents had no consent. The primary outcome was to assess the need for intubation within 72 hours of life. The secondary outcomes were complications for example intra ventricular hemorrhage, pneumothorax and feed intolerance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111930964N1
Registration date: 2016-12-30, 1395/10/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-30, 1395/10/10
Registrant information
Name
Shiva Bashirnejadkhabaz
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3226
Email address
bashirnejad.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2016-06-05, 1395/03/16
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of continuous positive oscillatory nasal airway pressure versus continuous positive nasal airway pressure in neonates with 28-34 weeks of gestational age with respiratory distress syndrome: A randomized controlled trial
Public title
Study of two non-invasive ventilation methods in the treatment of acute respiratory distress syndrome of infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Preterm infants at gestational age of 28 to 34 weeks; weight between 1000 and 2000 grams; respiratory distress syndrome; Silverman-Anderson retraction score 6 - 7. Exclusion criteria: Congenital malformation; cardiac disease; severe asphyxia (Apgar score ≤ 3 at 1 and 5 minute or pH ≤ 7.12); parents' unwillingness to participate in the study.
Age
To 1 day old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized based on a random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Ahvaz Jundishapur University of Medical Sciences
Street address
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
City
Ahvaz
Postal code
1579461357
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
IR.AJUMS.REC.1395.162

Health conditions studied

1

Description of health condition studied
respiratory distress syndrome in new borns
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Non-invasive ventilatory failure
Timepoint
During first 72 hours of birth
Method of measurement
A questionnaire was used to investigate the noninvasive ventilation failure within first 72 hours of birth in which data were collected based on observation and ABG. The failure criteria were met by at least 1 of the following: pH ≤ 7.20 and PaCO2 ≥ 60 mm Hg, PaO2 ≤ 50 mm Hg with a fraction of inspired oxygen ≥ 0.6 or respiratory distress increase, recurrent apnea with ≥ 3 episodes per hour associated with bradycardia, a single episode of apnea that required bag and mask ventilation.

Secondary outcomes

1

Description
Milk intolerance rate
Timepoint
Within admission period
Method of measurement
questionnaire

2

Description
Pneumothorax
Timepoint
Within first 72 h
Method of measurement
CXR

3

Description
IVH
Timepoint
At the end of first and fourth week or at the time of symptom incidence.
Method of measurement
brain sonography

Intervention groups

1

Description
Intervention 1: Eligible newborns were randomly allocated to the ‘Oscillatory NCPAP’ group. For this purpose, cno ncpap device ( made in Germany) was employed. Using this device, nasal continuous positive airway pressure with vibration was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure was measured at least every 6 hours. ABG was performed after 30 min of starting respiratory support, then, at least every 6 hours in first 24 hours and every 8 hours in next 24 h and as indicated. We used oscillatory NCPAP with PEEP 4-6 cm of water, fraction of inspired oxygen (Fio2) of 0.4, frequency of 3 HZ and amplitude of 3 cm H2O. Maximum permissible PEEP was 8 cm and maximum permissible Fio2 was 0.6. Maximum permissible frequency and amplitude were at the time that we observed oscillation on chest wall (Maximum frequency of 5 HZ and amplitude of 7 cm H2O). Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %.
Category
Treatment - Other

2

Description
Intervention 2: Eligible newborns were randomly allocated to the ‘NCPAP’ group. For this purpose, sindi ncpap device (made in Germany) was employed. Using this device, nasal continuous positive airway pressure was given to the patient. INSURE (intubation, surfactant treatment and extubation) technique would have been used if the patient had needed PEEP ≥5 cm/H2o and Fio2 ≥ 40%. The orogastric tube was kept open and suspended from the top wall of the incubator to decompress the stomach. Pulse oximeter saturation, respiratory rate and heart rate were continuously monitored. Blood pressure measured at least every 6 h. ABG was performed after 30 min of starting respiratory support, then, at least every 6 h in first 24 h and every 8 h in next 24 h and as indicated. We used NCPAP with PEEP equal to 4-6 cm of water and fraction of inspired oxygen (Fio2) equal to 0.4. Maximum permissible target was 8 cm for PEEP and 0.6 for Fio2. Settings was adjusted based on arterial blood gases (ABG) and clinical parameters. Targeted saturation was ≥ 90 %.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit of Imam Khomeini Hospital
Full name of responsible person
Shiva Bashirnejadkhabaz
Street address
Imam Khomeini Hospital, Azadegan street, Ahwaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad SharifMakhmalzadeh
Street address
Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences, Daneshgahi Settlements, Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shiva Bashirnejad khabaz
Position
Neonatology subspecialty trainee
Other areas of specialty/work
Street address
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
City
Ahvaz
Postal code
1579461357
Phone
+98 613367543
Fax
Email
bashirnejad.sh@ajums.ac.ir; sh.bashirnejad@gmail.com
Web page address
http://www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Arash Malekian
Position
Neonatologist
Other areas of specialty/work
Street address
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 613367543
Fax
Email
malekianarash@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shiva Bashirnejad khabaz
Position
Neonatology subspecialty trainee
Other areas of specialty/work
Street address
The main door of Ahvaz Jundishapur University of Medical Sciences and Health Services, opposite the Khuzestan Water and Electricity Authority (five storeys), Golestan highway, Ahvaz
City
Ahvaz
Postal code
1579461357
Phone
00
Fax
Email
bashirnejad.sh@ajums.ac.ir; sh.bashirnejad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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