An interventional study of CPAP and NIPPV in Respiratory Distress of Newborn, sponsored by Ministry of Health, Sri Lanka. Completed at 1 site in Sri Lanka. Open to participants aged 20 Minutes to 24 Hours. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by Ministry of Health, Sri Lanka · Not applicable, Interventional, and Treatment
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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 birth.Primary 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.
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 infant's nostrils.
CPAP started with Positive end expiratory pressure (PEEP) 05 and increased up to PEEP 09 according to the severity of baby's condition.
NIPPV started with intermittent Mandatory ventilation (IMV) rate 30, peak inspiratory pressure (PIP) 20 and PEEP 5.Increased the settings according to the severity of baby's 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.
377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Ministry of Health, Sri Lanka is the lead sponsor of 4 studies on the registry; none are open to participants now.
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All neonates with mild to moderate respiratory distress, requiring non invasive respiratory support on admission as defined by one or more of the following
Apnoea
Exclusion Criteria:
Major cardiac disease (not including patent ductus arteriosus [PDA]),
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Newborn with mild to moderate respiratory distress randomly allocated to CPAP arm. CPAP started with Positive End Expiatory Pressure(PEEEP) 05 and increased up to PEEP 09 according to the severity of baby's condition.
Device: CPAP
Newborn with mild to moderate respiratory distress randomly allocated to NIPPV arm. NIPPV started with Intermittent Mandatory Ventilation rate 30, Peak Inspiratory Pressure 20 and PEEP 5.Increased the settings according to the severity of baby's condition
Device: NIPPV
Non invasive respiratory support failure
Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.
Time frame: 72 hours
duration of respiratory support
Time in days to stop oxygen support and the neonate to be on room air without respiratory distress or apnoea.
Time frame: 21 days
length of hospital stay
The total duration of hospital stay in days.
Time frame: 28 days
Grade III and IV Intra Ventricular Haemorrhage (IVH)
Evidence of grade III or IV IVH from ultrasound scan of the brain.
Time frame: 14 days
time taken to achieve full enteral nutrition
Total time in days the neonate will receive total enteral feed without intravenous fluid.
Time frame: 21 days
Plan to share: No
Ran from Jan 2015 to primary completion in Dec 2015, 11 months.
Of 152 non-industry interventional studies with no phase under Pulmonary Atelectasis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 11 months is close to that.
Counting every sponsor, half of 154 studies reached it within 12 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Sri Lanka