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

Not Applicable

Completed

• Conditions: Respiratory Distress of Newborn
• Interventions: Device: NIPPV; Device: CPAP

• Registration Number: NCT03347136
• Lead Sponsor: Ministry of Health, Sri Lanka

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.

Study Timeline

• Study Start: 2015-01-10
• Primary Completion: 2015-12-15
• Study Completion: 2015-12-28
• Status Verified: 2017-11
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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]),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Newborns with NIPPV support	NIPPV	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
Newborns with CPAP support	CPAP	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.

Primary Outcome Measures

Name	Time	Method
Non invasive respiratory support failure	72 hours	Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.

Secondary Outcome Measures

Name	Time	Method
duration of respiratory support	21 days	Time in days to stop oxygen support and the neonate to be on room air without respiratory distress or apnoea.
time taken to achieve full enteral nutrition	21 days	Total time in days the neonate will receive total enteral feed without intravenous fluid.
length of hospital stay	28 days	The total duration of hospital stay in days.
Grade III and IV Intra Ventricular Haemorrhage (IVH)	14 days	Evidence of grade III or IV IVH from ultrasound scan of the brain.

Trial Locations

Locations (1)

Sri Jayawardanapura teaching hospital; 🇱🇰 Colombo, Western, Sri Lanka