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

Respiratory Distress of Newborn Clinical Trial

Official title:

Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347136
• Other study ID #: MOHSriLanka
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 16, 2017
• Start date: January 10, 2015
• Est. completion date: December 28, 2015

Study information

• Verified date: November 2017
• Source: Ministry of Health, Sri Lanka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 28, 2015
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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]),

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Respiratory Distress of Newborn
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• CPAP

• NIPPV

Locations

Country	Name	City	State
Sri Lanka	Sri Jayawardanapura teaching hospital	Colombo	Western

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Sri Lanka

Country where clinical trial is conducted

Sri Lanka, 

References & Publications (24)

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 — View 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. — View 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. Review. Erratum in: J Perinatol. 2010 Dec;30(12):827. — View 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. 200 — View 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. Epub 2007 Sep 5. Review. — View 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. Review. — View Citation

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

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 extubat — View Citation

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

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 respirator — View 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;10 — View 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 — View 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:CD003212. doi: — View 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:CD005384. doi: 10.1002/146 — View 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. — View 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 Chi — View 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. — View 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 Ap — View 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.

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. 201 — View 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. Review. — View 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 2 — View 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 Peri — View 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 dist

* Note: There are 24 references in all — Click here to view all references

Outcome

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

External Links

•   Mechanical ventilation in neonates.Version 19.3