Respiratory Distress of NewbornNCT03347136
Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation
A study testing CPAP and NIPPV in people with Respiratory Distress of Newborn, run by Ministry of Health, Sri Lanka at 1 site in Sri Lanka.
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… Read more about this study
- Who is it for?
- Ages 20 minutes to 24 hours
- Conditions the study is for
- Respiratory Distress of Newborn
- What is being tested?
- CPAP and NIPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSri Lanka
- Study dates
- 10 Jan 2015to 28 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 minutes to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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]),
- -
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
Sri Jayawardanapura teaching hospital
Colombo, Western Province, 10100
About this study
Official title: Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
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.
Read the 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.
- Conditions
- Respiratory Distress of Newborn
- Being tested
- CPAP, NIPPV
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
NIPPVDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: NIPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non invasive respiratory support failure
Failure of non invasive respiratory support by requirement for endotracheal ventilation with in 72 hours of starting treatment.
Measured: 72 hours
Secondary outcomes (4)
duration of respiratory support
Time in days to stop oxygen support and the neonate to be on room air without respiratory distress or apnoea.
Measured: 21 days
length of hospital stay
The total duration of hospital stay in days.
Measured: 28 days
Grade III and IV Intra Ventricular Haemorrhage (IVH)
Evidence of grade III or IV IVH from ultrasound scan of the brain.
Measured: 14 days
time taken to achieve full enteral nutrition
Total time in days the neonate will receive total enteral feed without intravenous fluid.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start10 Jan 2015
- Primary completion15 Dec 2015
- Study completion28 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Sri Lanka
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Anne kaushalya Shilani Gomez,MBBS,MD, Ministry of Health, Sri Lanka
- Investigators
- ANNE KS GOMEZ, MBBS,MD, Principal investigator, Teaching Hospital Mahamodara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347136
- Sponsor's protocol ID
- MOHSriLanka
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
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.
PubMed 19847188Perinatal 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.
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.
PubMed 11433048Santin 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.
PubMed 15141265Lin 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.
PubMed 9859905Barrington 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.
PubMed 11335736De 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.
PubMed 12650303Lemyre 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.
PubMed 28146296Meneses 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.
PubMed 21262883Sai 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.
PubMed 19523049Meneses 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.
PubMed 22474063Roberts 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.
PubMed 23989138Claure 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.
PubMed 17804519
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CPAP and NIPPV as a Mode of Non-invasive Respiratory Support for Neonates in a Level III NICU
- ClinicalTrials.gov ID
- NCT03347136
- Acronym / sponsor ID
- MOHSriLanka
- Conditions
- Respiratory Distress of Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ministry of Health, Sri LankaOther government
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 28 Dec 2015 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The neonates with mild to moderate respiratory distress were randomly allocated to tratment with NIPPV and CPAP.
| Arm | Type | Receives |
|---|---|---|
| Newborns with CPAP support | Active comparator | Device: CPAPNewborn 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. |
| Newborns with NIPPV support | Experimental | Device: NIPPVNewborn 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 |
Who may qualify
- Ages
- 20 minutes to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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]),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP | Device | Newborns with CPAP support |
| NIPPV | Device | Newborns with NIPPV support |
Primary outcome
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.
4 secondary outcomes
duration of respiratory support
Time frame: 21 days
length of hospital stay
Time frame: 28 days
Grade III and IV Intra Ventricular Haemorrhage (IVH)
Time frame: 14 days
time taken to achieve full enteral nutrition
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- BackgroundDK Guha, editors, Jaypee Brothers. NNF Recommended Basic Perinatal-Neonatal Nomenclature. Neonatology- Principles and Practice. 1st ed. New Delhi, 1998: 131-2
- BackgroundJ Crowther ANNP Updated by Dr Smith. East Cheshire NHS trust Endotracheal Intubation guide line February 2013 Version 2.0 3
- Background: PubMed 19847188Bhandari 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.
- BackgroundPerinatal 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 publication: PubMed 11433048Khalaf 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 publication: PubMed 15141265Santin 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 publication: PubMed 9859905Lin 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 publication: PubMed 11335736Barrington 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 publication: PubMed 12650303De 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 publication: PubMed 28146296Lemyre 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 publication: PubMed 21262883Meneses 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 publication: PubMed 19523049Sai 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.
- Mechanical ventilation in neonates.Version 19.3Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANNE KS GOMEZ, MBBS,MD principal investigator
Teaching Hospital Mahamodara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and NIPPV in people with Respiratory Distress of Newborn, run by Ministry of Health, Sri Lanka at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non invasive respiratory support failure (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347136, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.