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

Primary Purpose

Respiratory Distress of Newborn

Status
Completed
Phase
Not Applicable
Locations
Sri Lanka
Study Type
Interventional
Intervention
CPAP
NIPPV
Sponsored by
Ministry of Health, Sri Lanka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress of Newborn

Eligibility Criteria

20 Minutes - 24 Hours (Child)All SexesDoes not accept 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]),

    -

Sites / Locations

  • Sri Jayawardanapura teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Newborns with CPAP support

Newborns with NIPPV support

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 10, 2017
Last Updated
November 16, 2017
Sponsor
Ministry of Health, Sri Lanka
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1. Study Identification

Unique Protocol Identification Number
NCT03347136
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2015 (Actual)
Primary Completion Date
December 15, 2015 (Actual)
Study Completion Date
December 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Sri Lanka

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress of Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Newborns with CPAP support
Arm Type
Active Comparator
Arm 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.
Arm Title
Newborns with NIPPV support
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Type
Device
Intervention Name(s)
NIPPV
Primary Outcome Measure Information:
Title
Non invasive respiratory support failure
Description
Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
duration of respiratory support
Description
Time in days to stop oxygen support and the neonate to be on room air without respiratory distress or apnoea.
Time Frame
21 days
Title
length of hospital stay
Description
The total duration of hospital stay in days.
Time Frame
28 days
Title
Grade III and IV Intra Ventricular Haemorrhage (IVH)
Description
Evidence of grade III or IV IVH from ultrasound scan of the brain.
Time Frame
14 days
Title
time taken to achieve full enteral nutrition
Description
Total time in days the neonate will receive total enteral feed without intravenous fluid.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Minutes
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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 Respiratory distress needing 3L of O2 to maintain saturation of >90% Silverman Anderson score of 4 - 6 Apnoea >2 apnoeic attacks needing tactile stimulation for recovery. One apnoea needs resuscitation Exclusion Criteria: Major congenital anomalies Presence of cardiovascular instability {sepsis, anemia or severe intraventricular haemorrhage (IVH)}. Intubation needed on admission to the NICU Consent not provided or refused Major cardiac disease (not including patent ductus arteriosus [PDA]), -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANNE KS GOMEZ, MBBS,MD
Organizational Affiliation
Teaching Hospital Mahamodara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sri Jayawardanapura teaching hospital
City
Colombo
State/Province
Western
ZIP/Postal Code
10100
Country
Sri Lanka

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
DK Guha, editors, Jaypee Brothers. NNF Recommended Basic Perinatal-Neonatal Nomenclature. Neonatology- Principles and Practice. 1st ed. New Delhi, 1998: 131-2
Results Reference
background
Citation
J Crowther ANNP Updated by Dr Smith. East Cheshire NHS trust Endotracheal Intubation guide line February 2013 Version 2.0 3
Results Reference
background
PubMed Identifier
19847188
Citation
Bhandari V. Nasal intermittent positive pressure ventilation in the newborn: review of literature and evidence-based guidelines. J Perinatol. 2010 Aug;30(8):505-12. doi: 10.1038/jp.2009.165. Epub 2009 Oct 22. Erratum In: J Perinatol. 2010 Dec;30(12):827.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
11433048
Citation
Khalaf MN, Brodsky N, Hurley J, Bhandari V. A prospective randomized, controlled trial comparing synchronized nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure as modes of extubation. Pediatrics. 2001 Jul;108(1):13-7. doi: 10.1542/peds.108.1.13.
Results Reference
result
PubMed Identifier
15141265
Citation
Santin R, Brodsky N, Bhandari V. A prospective observational pilot study of synchronized nasal intermittent positive pressure ventilation (SNIPPV) as a primary mode of ventilation in infants > or = 28 weeks with respiratory distress syndrome (RDS). J Perinatol. 2004 Aug;24(8):487-93. doi: 10.1038/sj.jp.7211131.
Results Reference
result
PubMed Identifier
9859905
Citation
Lin CH, Wang ST, Lin YJ, Yeh TF. Efficacy of nasal intermittent positive pressure ventilation in treating apnea of prematurity. Pediatr Pulmonol. 1998 Nov;26(5):349-53. doi: 10.1002/(sici)1099-0496(199811)26:53.0.co;2-7.
Results Reference
result
PubMed Identifier
11335736
Citation
Barrington KJ, Bull D, Finer NN. Randomized trial of nasal synchronized intermittent mandatory ventilation compared with continuous positive airway pressure after extubation of very low birth weight infants. Pediatrics. 2001 Apr;107(4):638-41. doi: 10.1542/peds.107.4.638.
Results Reference
result
PubMed Identifier
12650303
Citation
De Paoli AG, Davis PG, Lemyre B. Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review and meta-analysis. Acta Paediatr. 2003;92(1):70-5. doi: 10.1111/j.1651-2227.2003.tb00472.x.
Results Reference
result
PubMed Identifier
28146296
Citation
Lemyre B, Davis PG, De Paoli AG, Kirpalani H. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD003212. doi: 10.1002/14651858.CD003212.pub3.
Results Reference
result
PubMed Identifier
21262883
Citation
Meneses J, Bhandari V, Alves JG, Herrmann D. Noninvasive ventilation for respiratory distress syndrome: a randomized controlled trial. Pediatrics. 2011 Feb;127(2):300-7. doi: 10.1542/peds.2010-0922. Epub 2011 Jan 24.
Results Reference
result
PubMed Identifier
19523049
Citation
Sai Sunil Kishore M, Dutta S, Kumar P. Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure for respiratory distress syndrome. Acta Paediatr. 2009 Sep;98(9):1412-5. doi: 10.1111/j.1651-2227.2009.01348.x. Epub 2009 Jun 12.
Results Reference
result
PubMed Identifier
22474063
Citation
Meneses J, Bhandari V, Alves JG. Nasal intermittent positive-pressure ventilation vs nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2012 Apr;166(4):372-6. doi: 10.1001/archpediatrics.2011.1142.
Results Reference
result
PubMed Identifier
23989138
Citation
Roberts CT, Davis PG, Owen LS. Neonatal non-invasive respiratory support: synchronised NIPPV, non-synchronised NIPPV or bi-level CPAP: what is the evidence in 2013? Neonatology. 2013;104(3):203-9. doi: 10.1159/000353448. Epub 2013 Aug 28.
Results Reference
result
PubMed Identifier
17804519
Citation
Claure N, Bancalari E. New modes of mechanical ventilation in the preterm newborn: evidence of benefit. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F508-12. doi: 10.1136/adc.2006.108852. Epub 2007 Sep 5. No abstract available.
Results Reference
result
PubMed Identifier
17452229
Citation
Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032.
Results Reference
result
PubMed Identifier
27976361
Citation
Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD005384. doi: 10.1002/14651858.CD005384.pub2.
Results Reference
result
PubMed Identifier
17404558
Citation
Bisceglia M, Belcastro A, Poerio V, Raimondi F, Mesuraca L, Crugliano C, Corapi UP. A comparison of nasal intermittent versus continuous positive pressure delivery for the treatment of moderate respiratory syndrome in preterm infants. Minerva Pediatr. 2007 Apr;59(2):91-5.
Results Reference
result
PubMed Identifier
22301528
Citation
Ramanathan R, Sekar KC, Rasmussen M, Bhatia J, Soll RF. Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants <30 weeks' gestation: a randomized, controlled trial. J Perinatol. 2012 May;32(5):336-43. doi: 10.1038/jp.2012.1. Epub 2012 Feb 2. Erratum In: J Perinatol. 2012 May;32(5):395.
Results Reference
result
PubMed Identifier
25709790
Citation
Armanian AM, Badiee Z, Heidari G, Feizi A, Salehimehr N. Initial Treatment of Respiratory Distress Syndrome with Nasal Intermittent Mandatory Ventilation versus Nasal Continuous Positive Airway Pressure: A Randomized Controlled Trial. Int J Prev Med. 2014 Dec;5(12):1543-51.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
19948523
Citation
Lista G, Castoldi F, Fontana P, Daniele I, Cavigioli F, Rossi S, Mancuso D, Reali R. Nasal continuous positive airway pressure (CPAP) versus bi-level nasal CPAP in preterm babies with respiratory distress syndrome: a randomised control trial. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F85-9. doi: 10.1136/adc.2009.169219. Epub 2009 Nov 29.
Results Reference
result
PubMed Identifier
10685270
Citation
Friedlich P, Lecart C, Posen R, Ramicone E, Chan L, Ramanathan R. A randomized trial of nasopharyngeal-synchronized intermittent mandatory ventilation versus nasopharyngeal continuous positive airway pressure in very low birth weight infants after extubation. J Perinatol. 1999 Sep;19(6 Pt 1):413-8. doi: 10.1038/sj.jp.7200205.
Results Reference
result
PubMed Identifier
26135774
Citation
Jasani B, Nanavati R, Kabra N, Rajdeo S, Bhandari V. Comparison of non-synchronized nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure as post-extubation respiratory support in preterm infants with respiratory distress syndrome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(10):1546-51. doi: 10.3109/14767058.2015.1059809. Epub 2015 Jul 28.
Results Reference
result
Links:
URL
https://www.uptodate.com
Description
Mechanical ventilation in neonates.Version 19.3

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

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