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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347136
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Anne kaushalya Shilani Gomez,MBBS,MD, Ministry of Health, Sri Lanka

Study Description
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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.


Condition or disease Intervention/treatment Phase
Respiratory Distress of Newborn Device: CPAP Device: NIPPV Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.
Masking: None (Open Label)
Masking Description: Due to type of intervention masking was not possible.
Primary Purpose: Treatment
Official Title: Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
Actual Study Start Date : January 10, 2015
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : December 28, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Newborns with CPAP support
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
Experimental: Newborns with NIPPV support
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


Outcome Measures
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Primary Outcome Measures :
  1. Non invasive respiratory support failure [ Time Frame: 72 hours ]
    Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.


Secondary Outcome Measures :
  1. duration of respiratory support [ Time Frame: 21 days ]
    Time in days to stop oxygen support and the neonate to be on room air without respiratory distress or apnoea.

  2. length of hospital stay [ Time Frame: 28 days ]
    The total duration of hospital stay in days.

  3. Grade III and IV Intra Ventricular Haemorrhage (IVH) [ Time Frame: 14 days ]
    Evidence of grade III or IV IVH from ultrasound scan of the brain.

  4. time taken to achieve full enteral nutrition [ Time Frame: 21 days ]
    Total time in days the neonate will receive total enteral feed without intravenous fluid.


Eligibility Criteria
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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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]),

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347136


Locations
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Sri Lanka
Sri Jayawardanapura teaching hospital
Colombo, Western, Sri Lanka, 10100
Sponsors and Collaborators
Ministry of Health, Sri Lanka
Investigators
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Principal Investigator: ANNE KS GOMEZ, MBBS,MD Teaching Hospital Mahamodara
More Information
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Additional Information:

Publications of Results:
Wood FE, Gupta S, Tin W, Sinha S. Randomised controlled trial of synchronised intermittent positive airway pressure (SiPAP) versus continuous positive airway pressure (CPAP) as a primary mode of respiratory support in preterm infants with respiratory distress syndrome. Archives of Disease in Childhood 2013;98(Suppl 1):A1-117.

Other Publications:
DK Guha, editors, Jaypee Brothers. NNF Recommended Basic Perinatal-Neonatal Nomenclature. Neonatology- Principles and Practice. 1st ed. New Delhi, 1998: 131-2
J Crowther ANNP Updated by Dr Smith. East Cheshire NHS trust Endotracheal Intubation guide line February 2013 Version 2.0 3
Perinatal society of Sri Lanka in collaborating with WHO collaborating centre for training and research in new born care, All India Institute of Medical Science.Work book on neonatal ventilation.Learner's guide April 2008.

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Responsible Party: Dr. Anne kaushalya Shilani Gomez,MBBS,MD, acting consultant neonatologist, Ministry of Health, Sri Lanka
ClinicalTrials.gov Identifier: NCT03347136    
Other Study ID Numbers: MOHSriLanka
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyaline Membrane Disease
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases