Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03347136
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2017-11-10
Brief Title:
Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation
Sponsor:
Ministry of Health Sri Lanka
Organization:
Ministry of Health Sri Lanka
Study Overview
Official Title:
Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to compare the effectiveness of treatment with Non Invasive Positive Pressure Ventilation NIPPV and continuous positive airway pressure CPAP in decreasing the requirement for endotracheal ventilation in neonates with respiratory distress within the first hours of birthPrimary outcome is the non invasive respiratory support failure and the need for intubated ventilatory support during the first 72 hours of life
Randomized control single center trial Eighty neonates admitted to Neonatal Intensive Care Unit NICU were randomly allocated to NIPPV and CPAP Outcomes of respiratory support were observed and information on risk factors were obtained by going through bed head ticket
Randomized control single center trial Eighty neonates admitted to Neonatal Intensive Care Unit NICU were randomly allocated to NIPPV and CPAP Outcomes of respiratory support were observed and information on risk factors were obtained by going through bed head ticket
Detailed Description:
Objective of the study
To compare the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress
Specific objectives To determine the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress To describe neonatal factors associated with CPAP and NIPPV support To compare the length of hospital stay in neonates who received CPAP and NIPPV To compare the time taken to achieve full enteral nutrition in neonates who received CPAP and NIPPV
Study design
Randomized controlled trial
Study setting
Study carried out in NICU of the Sri Jayawardanapura General Hospital There are 06 ventilators in NICU of Sri Jayawardanapura Hospital Three SLE 2000 infant ventilators and three Bear CUB 750 psv infant ventilators Respiratory support conventional ventilation CPAP and NIPPV gave through these ventilators The neonatal soft tip curved nasal canula with tubing will be use for non invasive respiratory support The nasal canula connected to the ventilator via an endotracheal tube connector Systems were regularly monitored Canula size was chosen to comfortably fit the infants nostrils
CPAP started with Positive end expiratory pressure PEEP 05 and increased up to PEEP 09 according to the severity of babys condition
NIPPV started with intermittent Mandatory ventilation IMV rate 30 peak inspiratory pressure PIP 20 and PEEP 5Increased the settings according to the severity of babys condition
Sampling Method All neonates fulfilling inclusion and exclusion criteria registered in the study And a serial number issued They were allocated to the two arms of study randomly based on a previously generated random allocation schedule
They were managed according to hospital management protocol and outcome data were collected from the bed head ticket
The ethical approval taken from the Ethical Review Committee of Sri Jayawardenepura General Hospital kotte
Approval taken from Medical Technology and supplies sub committee on clinical trials Written informed consent obtained from parents or guardians of eligible infants before randomization The data sheets did not contain the name and be anonymous Data stored under lock and key with restricted access only to the principal investigators The computerized data were password protected and is only available to the investigators
To compare the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress
Specific objectives To determine the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress To describe neonatal factors associated with CPAP and NIPPV support To compare the length of hospital stay in neonates who received CPAP and NIPPV To compare the time taken to achieve full enteral nutrition in neonates who received CPAP and NIPPV
Study design
Randomized controlled trial
Study setting
Study carried out in NICU of the Sri Jayawardanapura General Hospital There are 06 ventilators in NICU of Sri Jayawardanapura Hospital Three SLE 2000 infant ventilators and three Bear CUB 750 psv infant ventilators Respiratory support conventional ventilation CPAP and NIPPV gave through these ventilators The neonatal soft tip curved nasal canula with tubing will be use for non invasive respiratory support The nasal canula connected to the ventilator via an endotracheal tube connector Systems were regularly monitored Canula size was chosen to comfortably fit the infants nostrils
CPAP started with Positive end expiratory pressure PEEP 05 and increased up to PEEP 09 according to the severity of babys condition
NIPPV started with intermittent Mandatory ventilation IMV rate 30 peak inspiratory pressure PIP 20 and PEEP 5Increased the settings according to the severity of babys condition
Sampling Method All neonates fulfilling inclusion and exclusion criteria registered in the study And a serial number issued They were allocated to the two arms of study randomly based on a previously generated random allocation schedule
They were managed according to hospital management protocol and outcome data were collected from the bed head ticket
The ethical approval taken from the Ethical Review Committee of Sri Jayawardenepura General Hospital kotte
Approval taken from Medical Technology and supplies sub committee on clinical trials Written informed consent obtained from parents or guardians of eligible infants before randomization The data sheets did not contain the name and be anonymous Data stored under lock and key with restricted access only to the principal investigators The computerized data were password protected and is only available to the investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None