Comparison of neonatal mortality and morbidity after separation from ventilator by positive pressure, suction and non-intervention methods
Design
A double-blind randomized clinical trial with parallel and control groups, Phase 2, involving 65 neonates, 38% in the positive pressure intervention and negative pressure suction groups (19 in each group), and 27 in the spontaneous octopus
Settings and conduct
in tube newborns in Ayatollah Taleghani in Ilam, who have the necessary conditions to be extubated, will enter in positive pressure, suction with negative pressure, and spontaneous extubation. The study was double-blind and the intervention infants and evaluators were unaware of the type of allocation in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- All newborns who are connected to a ventilator and have an order of extubation
2-Written informed consent of parents
Exclusion criteria
1- All newborns with congenital anomalies
Intervention groups
Intervention group 1: Separation of neonates from ventilator using positive pressure ventilation method, Intervention group 2: Separation of neonates from ventilator using negative pressure suction method and control group: Spontaneous separation
Main outcome variables
Co2 pressure,re-insertion of endotracheal intubation,Re-need for artificial ventilation,extensive atelectasis, increased respiratory effort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110523006575N6
Registration date:2021-09-18, 1400/06/27
Registration timing:retrospective
Last update:2021-09-18, 1400/06/27
Update count:0
Registration date
2021-09-18, 1400/06/27
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-11, 1400/02/21
Expected recruitment end date
2021-09-12, 1400/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neonatal mortality and morbidity after separation from ventilator by positive pressure, suction and non-intervention methods
Public title
Comparison of neonatal mortality and morbidity after separation from ventilator by positive pressure, suction and non-intervention methods
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All newborns who connected to a ventilator and have an order of ventilator separation
Exclusion criteria:
Congenital anomalies
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
19 cards with the title of intervention 1, 19 cards with the title of intervention 2, and 27 cards with the title of control will be placed in 65 envelopes of the same shape. The envelopes are placed irregularly and one envelope is opened for each newborn from one side
Blinding (investigator's opinion)
Double blinded
Blinding description
Newborns will not have an understanding of the type of intervention.
Extubation in positive pressure support, negative pressure suction and the automatically group will be done without the presence of evaluators. Documents will be registered in 3 groups A, B, C. Evaluators will record the results of the study only on a group basis and without knowing the type of allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ]مشئ University of Medical Sciences
Street address
Pajouhesh Blvd, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.MEDILAM.REC.1400.014
Health conditions studied
1
Description of health condition studied
Comparison of neonatal mortality and morbidity after separation from ventilator by positive pressure, suction and non-intervention methods
ICD-10 code
ICD-10 code description
Weaning
Primary outcomes
1
Description
Re-intubation
Timepoint
Regularly during the treatment period
Method of measurement
Documentation File
2
Description
Mortality
Timepoint
Regularly during the treatment period
Method of measurement
Documentation File
3
Description
Pneumothorax
Timepoint
Regularly during the treatment period
Method of measurement
Chest radiography
4
Description
Oxygen saturation
Timepoint
Regularly during the treatment period
Method of measurement
Pulse oximeter
5
Description
Duration of hospitalization
Timepoint
Regularly during the treatment period
Method of measurement
Documentation File
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Positive pressure support, with expanding ammo bag and squeezing ambos 3-4 times, will slowly separate
Category
Treatment - Devices
2
Description
Intervention group: Suction with a pressure of 100-80 mm Hg to which the N.G tube is connected will be used. At the same time as the negative pressure is applied, the endotracheal tube will be pulled out
Category
Treatment - Devices
3
Description
Control group: Spontaneous extubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital, Ilam University of Medical sciences, Ilam, Iran