Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation

Ministry of Health, Sri Lanka

Status: Completed

Conditions: Respiratory Distress of Newborn

Treatments: Device: NIPPV; Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03347136

MOHSriLanka

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 minutes to 24 hours old

Volunteers: No Healthy Volunteers

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]),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Newborns with CPAP support

Active Comparator group

Description:

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.

Treatment:

Device: CPAP

Newborns with NIPPV support

Experimental group

Description:

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

Treatment:

Device: NIPPV