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

NCT03347136 | Completed

• 1 other identifier: MOHSriLanka
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress of Newborn

Outcome Measures

Primary Outcomes (1)

• Non invasive respiratory support failure

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

  72 hours

Secondary Outcomes (4)

• duration of respiratory support

  21 days

• length of hospital stay

  28 days

• Grade III and IV Intra Ventricular Haemorrhage (IVH)

  14 days

• time taken to achieve full enteral nutrition

  21 days

Study Arms (2)

Newborns with CPAP support

ACTIVE COMPARATOR

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

Newborns with NIPPV support

EXPERIMENTAL

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

Interventions

CPAP DEVICE

Newborns with CPAP support

NIPPV DEVICE

Newborns with NIPPV support

Eligibility Criteria

• Age: 20 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 \[PDA\]),

Sponsors & Collaborators

• Ministry of Health, Sri Lanka: lead

Study Sites (1)

Sri Jayawardanapura teaching hospital

Colombo, Western Province, 10100, Sri Lanka

Location

Related Publications (24)

• DK Guha, editors, Jaypee Brothers. NNF Recommended Basic Perinatal-Neonatal Nomenclature. Neonatology- Principles and Practice. 1st ed. New Delhi, 1998: 131-2

  BACKGROUND

• J Crowther ANNP Updated by Dr Smith. East Cheshire NHS trust Endotracheal Intubation guide line February 2013 Version 2.0 3

  BACKGROUND

• 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.

  PMID: 19847188 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11433048 RESULT

• 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.

  PMID: 15141265 RESULT

• 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.

  PMID: 9859905 RESULT

• 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.

  PMID: 11335736 RESULT

• 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.

  PMID: 12650303 RESULT

• 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.

  PMID: 28146296 RESULT

• 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.

  PMID: 21262883 RESULT

• 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.

  PMID: 19523049 RESULT

• 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.

  PMID: 22474063 RESULT

• 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.

  PMID: 23989138 RESULT

• 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.

  PMID: 17804519 RESULT

• 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.

  PMID: 17452229 RESULT

• 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.

  PMID: 27976361 RESULT

• 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.

  PMID: 17404558 RESULT

• 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.

  PMID: 22301528 RESULT

• 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.

  PMID: 25709790 RESULT

• 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.

  RESULT

• 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.

  PMID: 19948523 RESULT

• 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.

  PMID: 10685270 RESULT

• 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.

  PMID: 26135774 RESULT

Related Links

• Mechanical ventilation in neonates.Version 19.3

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• ANNE KS GOMEZ, MBBS,MD

  Teaching Hospital Mahamodara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to type of intervention masking was not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: acting consultant neonatologist

Model Details: The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 20, 2017
• Study Start: January 10, 2015
• Primary Completion: December 15, 2015
• Study Completion: December 28, 2015
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)