Respiratory Distress SyndromePhase 4NCT00368680
Early CPAP in Respiratory Distress Syndrome
A Phase 4 study testing Early Bubble CPAP in people with Respiratory Distress Syndrome, run by Pontificia Universidad Catolica de Chile at 14 sites in 5 countries.
Trial summary
The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. Read more about this study
- Who is it for?
- Ages 5 to 30 minutes
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Early Bubble CPAP
- Type of treatment
- Medical device
- How many people
- 256 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Jan 2007to Sep 2009
- Phase
- Phase 4
- 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 5 to 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
- An informed consent form should be obtained preferable prenatal.
Who cannot join
- Acute life threatening congenital malformations or genetics diseases.
- Apgar score equal or less than 3 at 5 minutes
- Disapproval of informed consent.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Chile6 sites, 5 recruiting
- Recruiting
Servicio de Neonatología, Hospital Guillermo Grant
Concepción, Biobio
Aldo Bancalari, MD, abancalari@entelchile.net
Aldo Bancalari, MD
- Recruiting
Servicio de Neonatología, Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan
Jaime Burgos, MD, jfburgosm@hotmail.com
Jaime Burgos, MD
- Not yet recruiting
Servicio de Neonatología, Hospital San José
Santiago, Santiago Metropolitan
Agustina Gonzalez, MD, 56-2-3832600 ext. 2731, tinigonzalez3@yahoo.es
Agustina Gonzalez, MD
- Not yet recruiting
Servicio de Neonatología, Hospital Sótero del Rio
Santiago, Santiago Metropolitan
Patricia Mena, MD, 56-2-3536000 ext. 6535, pmena@uec.uchile.cl
Patricia Mena, MD
- Recruiting
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
Santiago, Santiago Metropolitan
Soledad Urzúa, MD, 56-2-3543348, soleurzua@gmail.com
José Luis Tapia, MD, 56-2-3546437, jlta@med.puc.cl
- Suspended
Servicio de Neonatología, Hospital Gustavo Fricke
Viña del Mar, Valparaiso
Argentina5 sites, 5 recruiting
- Recruiting
Servicio de Neonatología, Hospital de Clínicas José de San Martín
Buenos Aires
Isabel Kurlat, ikurlat@hospitaldeclinicas.uba.ar
Isabel Kurlat, MD
- Recruiting
Servicio de Neonatología, Hospital Fernández
Buenos Aires
Liliana Roldan, MD, liedro@gmail.com
Liliana Roldan, MD
- Recruiting
Servicio de Neonatología, Hospital Italiano
Buenos Aires
Gonzalo Mariani, MD, gonzalo.mariani@hospitalitaliano.org.ar
Gonzalo Mariani, MD
- Recruiting
Servicio de Neonatología, Maternidad Sardá
Buenos Aires
Carlos Grandi, MD, cgrandi@intramed.net
Javier Meritano, MD, jmeritano@gmail.com
- Recruiting
Servicio de Neonatología, Hospital Lagomaggiore
Mendoza
Augusto Fischetti, MD, afischetti@supernet.com.ar
Augusto Fischetti, MD
Paraguay1 site, 1 recruiting
- Not yet recruiting
Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
Asunción
José Lacarruba, MD, laca@conexion.com.py
Elizabeth Cespedes, MD, elizabethcespedes@yahoo.com.ar
Peru1 site, 1 recruiting
- Recruiting
Servicio de Neonatología, Hospital Cayetano Heredia
Lima
Jaime Zegarra, MD, zegpach@upch.edu.pe
Fabiola Rivera, MD, fabiolariveraab@yahoo.com
Uruguay1 site, 1 recruiting
- Not yet recruiting
Servicio de neonatología, Centro Hospitalario Pereira Rosseli
Montevideo
Ruben Panizza, MD, rubenpanizza@montevideo.com.uy
Ruben Panizza, MD
About this study
Official title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.
Read the detailed description
The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.
Hypothesis:
- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.
The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .
As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
Comparison(s):
Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Early Bubble CPAP
- Keywords
- Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Bubble CPAPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for mechanical ventilation
Secondary outcomes (8)
Days of oxygen therapy
Days of mechanical ventilation
Need for surfactant
Pulmonary airleak
Intraventricular hemorrhage
Persistent ductus arteriosus
retinopathy of prematurity
Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startJan 2007
- Primary completionApr 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Investigators
- José Luis Tapia, MD, Principal investigator, Pontificia Universidad CatólicaAldo Bancalari, MD, Principal investigator, Hospital Guillermo GrantSoledad Urzua, MD, Principal investigator, Pontificia Universidad Católica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368680
- Sponsor's protocol ID
- NEO032006
- Status last verified
- Apr 2007
- First submitted
- 24 Aug 2006
- Last updated
- 24 Dec 2010
- Results posted
- No
Publications
Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
PubMed 4930602Krouskop RW, Brown EG, Sweet AY. The early use of continuous positive airway pressure in the treatment of idiopathic respiratory distress syndrome. J Pediatr. 1975 Aug;87(2):263-7. doi: 10.1016/s0022-3476(75)80599-3.
PubMed 1097619Allen LP, Reynolds ER, Rivers RP, Le Souef PM, Wimberley PD. Controlled trial of continuous positive airway pressure given by face mask for hyaline membrane disease. Arch Dis Child. 1977 May;52(5):373-8. doi: 10.1136/adc.52.5.373.
PubMed 326199Hegyi T, Hiatt IM. The effect of continuous positive airway pressure on the course of respiratory distress syndrome: the benefits on early initiation. Crit Care Med. 1981 Jan;9(1):38-41. doi: 10.1097/00003246-198101000-00009.
PubMed 6780266Kamper J, Wulff K, Larsen C, Lindequist S. Early treatment with nasal continuous positive airway pressure in very low-birth-weight infants. Acta Paediatr. 1993 Feb;82(2):193-7. doi: 10.1111/j.1651-2227.1993.tb12637.x.
PubMed 8477167Kamper J. Early nasal continuous positive airway pressure and minimal handling in the treatment of very-low-birth-weight infants. Biol Neonate. 1999 Jun;76 Suppl 1:22-8. doi: 10.1159/000047043.
PubMed 10393390Lundstrom KE. Initial treatment of preterm infants--continuous positive airway pressure or ventilation? Eur J Pediatr. 1996 Aug;155 Suppl 2:S25-9. doi: 10.1007/BF01958077.
PubMed 8839743Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N, Leviton A. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000 Jun;105(6):1194-201. doi: 10.1542/peds.105.6.1194.
PubMed 10835057Michna J, Jobe AH, Ikegami M. Positive end-expiratory pressure preserves surfactant function in preterm lambs. Am J Respir Crit Care Med. 1999 Aug;160(2):634-9. doi: 10.1164/ajrccm.160.2.9902016.
PubMed 10430740Verder H, Albertsen P, Ebbesen F, Greisen G, Robertson B, Bertelsen A, Agertoft L, Djernes B, Nathan E, Reinholdt J. Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks' gestation. Pediatrics. 1999 Feb;103(2):E24. doi: 10.1542/peds.103.2.e24.
PubMed 9925870Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.
PubMed 12076463Subramaniam P, Henderson-Smart DJ, Davis PG. Prophylactic nasal continuous positive airways pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001243. doi: 10.1002/14651858.CD001243.pub2.
PubMed 16034858Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75. doi: 10.1159/000013962.
PubMed 9483299De Klerk AM, De Klerk RK. Nasal continuous positive airway pressure and outcomes of preterm infants. J Paediatr Child Health. 2001 Apr;37(2):161-7. doi: 10.1046/j.1440-1754.2001.00624.x.
PubMed 11328472Narendran V, Donovan EF, Hoath SB, Akinbi HT, Steichen JJ, Jobe AH. Early bubble CPAP and outcomes in ELBW preterm infants. J Perinatol. 2003 Apr-May;23(3):195-9. doi: 10.1038/sj.jp.7210904.
PubMed 12732855
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
- ClinicalTrials.gov ID
- NCT00368680
- Acronym / sponsor ID
- NEO032006
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2008
- Study completion
- Sep 2009
- First posted
- 25 Aug 2006 (estimated)
- 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 purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.
Detailed description
The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.
Hypothesis:
- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.
The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .
As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
Comparison(s):
Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
- An informed consent form should be obtained preferable prenatal.
Key exclusion criteria (3 listed)
- Acute life threatening congenital malformations or genetics diseases.
- Apgar score equal or less than 3 at 5 minutes
- Disapproval of informed consent.
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 |
|---|---|---|
| Early Bubble CPAP | Device | – |
Primary outcome
Need for mechanical ventilation
8 secondary outcomes
Days of oxygen therapy
Days of mechanical ventilation
Need for surfactant
Pulmonary airleak
Intraventricular hemorrhage
Persistent ductus arteriosus
retinopathy of prematurity
Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Background: PubMed 4930602Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
- Background: PubMed 1097619Krouskop RW, Brown EG, Sweet AY. The early use of continuous positive airway pressure in the treatment of idiopathic respiratory distress syndrome. J Pediatr. 1975 Aug;87(2):263-7. doi: 10.1016/s0022-3476(75)80599-3.
- Background: PubMed 326199Allen LP, Reynolds ER, Rivers RP, Le Souef PM, Wimberley PD. Controlled trial of continuous positive airway pressure given by face mask for hyaline membrane disease. Arch Dis Child. 1977 May;52(5):373-8. doi: 10.1136/adc.52.5.373.
- Background: PubMed 6780266Hegyi T, Hiatt IM. The effect of continuous positive airway pressure on the course of respiratory distress syndrome: the benefits on early initiation. Crit Care Med. 1981 Jan;9(1):38-41. doi: 10.1097/00003246-198101000-00009.
- Background: PubMed 8477167Kamper J, Wulff K, Larsen C, Lindequist S. Early treatment with nasal continuous positive airway pressure in very low-birth-weight infants. Acta Paediatr. 1993 Feb;82(2):193-7. doi: 10.1111/j.1651-2227.1993.tb12637.x.
- Background: PubMed 10393390Kamper J. Early nasal continuous positive airway pressure and minimal handling in the treatment of very-low-birth-weight infants. Biol Neonate. 1999 Jun;76 Suppl 1:22-8. doi: 10.1159/000047043.
- Background: PubMed 8839743Lundstrom KE. Initial treatment of preterm infants--continuous positive airway pressure or ventilation? Eur J Pediatr. 1996 Aug;155 Suppl 2:S25-9. doi: 10.1007/BF01958077.
- Background: PubMed 10835057Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N, Leviton A. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000 Jun;105(6):1194-201. doi: 10.1542/peds.105.6.1194.
- Background: PubMed 10430740Michna J, Jobe AH, Ikegami M. Positive end-expiratory pressure preserves surfactant function in preterm lambs. Am J Respir Crit Care Med. 1999 Aug;160(2):634-9. doi: 10.1164/ajrccm.160.2.9902016.
- Background: PubMed 9925870Verder H, Albertsen P, Ebbesen F, Greisen G, Robertson B, Bertelsen A, Agertoft L, Djernes B, Nathan E, Reinholdt J. Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks' gestation. Pediatrics. 1999 Feb;103(2):E24. doi: 10.1542/peds.103.2.e24.
- Background: PubMed 12076463Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.
- Background: PubMed 16034858Subramaniam P, Henderson-Smart DJ, Davis PG. Prophylactic nasal continuous positive airways pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001243. doi: 10.1002/14651858.CD001243.pub2.
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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.
José Luis Tapia, MD principal investigator
Pontificia Universidad Católica
Aldo Bancalari, MD principal investigator
Hospital Guillermo Grant
Soledad Urzua, MD principal investigator
Pontificia Universidad Católica
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early Bubble CPAP in people with Respiratory Distress Syndrome, run by Pontificia Universidad Catolica de Chile at 14 sites in 5 countries.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Chile, Argentina, Paraguay, Peru, Uruguay. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Luis Tapia, MD (56-2-3546437, jlta@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for mechanical ventilation. 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 NCT00368680, which also lists 16 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 24 Dec 2010.