Clinical trial NCT03347136: Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation
Official title: Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress of Newborn
Lead sponsor: Ministry of Health, Sri Lanka
Sponsor class: OTHER_GOV
First posted: 2017-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

All neonates with mild to moderate respiratory distress, requiring non invasive respiratory support on admission as defined by one or more of the following

1. Respiratory distress needing 3L of O2 to maintain saturation of \>90%
2. Silverman Anderson score of 4 - 6
3. Apnoea

   1. \>2 apnoeic attacks needing tactile stimulation for recovery.
   2. One apnoea needs resuscitation

Exclusion Criteria:

1. Major congenital anomalies
2. Presence of cardiovascular instability {sepsis, anemia or severe intraventricular haemorrhage (IVH)}.
3. Intubation needed on admission to the NICU
4. Consent not provided or refused
5. Major cardiac disease (not including patent ductus arteriosus \[PDA\]),

   -

Primary outcomes:
measure: Non invasive respiratory support failure
timeFrame: 72 hours
Secondary outcomes:
measure: duration of respiratory support
timeFrame: 21 days
measure: length of hospital stay
timeFrame: 28 days
measure: Grade III and IV Intra Ventricular Haemorrhage (IVH)
timeFrame: 14 days
measure: time taken to achieve full enteral nutrition
timeFrame: 21 days
Other outcomes:
Locations:
city: Colombo
country: Sri Lanka
facility: Sri Jayawardanapura teaching hospital
state: Western
Study officials:
affiliation: Teaching Hospital Mahamodara
name: ANNE KS GOMEZ, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
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