Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00821119
Other study ID # IMIP123
Secondary ID
Status Completed
Phase N/A
First received January 12, 2009
Last updated March 3, 2013
Start date August 2007
Est. completion date September 2009

Study information

Verified date March 2013
Source Instituto Materno Infantil Prof. Fernando Figueira
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)


Description:

Respiratory distress syndrome(RDS) and its sequelae, bronchopulmonary dysplasia(BPD) are complications of prematurity.The pathogenesis of BPD is multifactorial and one of the most important risk factors is the ventilator-induced lung injury caused by invasive respiratory support.

The two modes of non-invasive ventilation, NIPP and specially NCPAP, have been used frequently in the respiratory care of preterm infants in neonatal units.NCPAP is currently a common practice for the treatment of RDS . NIPP has been found to be more effective than NCPAP in apnea of prematurity and immediately after extubation in preterm infants,decreasing the need of endotracheal ventilation.

Alternative techniques of non-invasive ventilation has been suggested in some studies to decrease respiratory morbidities associated with prematurity.This non-invasive approach could be used initially as a primary mode of ventilation for infants with RDS in a effort to decrease lung injury and BPD.Studies are needed to compare the effectiveness of these therapies.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Day
Eligibility Inclusion Criteria:

- preterm infants with RDS

- assigned to non invasive ventilation

Exclusion Criteria:

- preterm on endotracheal ventilation

- severe congenital pulmonary or cardiovascular malformation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
nasal intermittent positive pressure ventilation
Nasal intermittent positive airway pressure will be compared are the nasal continuous positive pressure as an initial ventilatory mode in preterm infants with respiratory distress syndrome

Locations

Country Name City State
Brazil Instituto materno Infantil Fernando Figueira Recife Pernambuco
Brazil Maternal Infant Institute Prof Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Ambalavanan N, Carlo WA. Ventilatory strategies in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):192-9. Review. — View Citation

Bancalari E, del Moral T. Continuous positive airway pressure: early, late, or stay with synchronized intermittent mandatory ventilation? J Perinatol. 2006 May;26 Suppl 1:S33-7; discussion S43-5. Review. — View Citation

Bhandari V, Gavino RG, Nedrelow JH, Pallela P, Salvador A, Ehrenkranz RA, Brodsky NL. A randomized controlled trial of synchronized nasal intermittent positive pressure ventilation in RDS. J Perinatol. 2007 Nov;27(11):697-703. Epub 2007 Aug 16. — 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

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. — View Citation

Manzar S, Nair AK, Pai MG, Paul J, Manikoth P, Georage M, Al-Khusaiby SM. Use of nasal intermittent positive pressure ventilation to avoid intubation in neonates. Saudi Med J. 2004 Oct;25(10):1464-7. — 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 Perinatol. 2004 Aug;24(8):487-93. — View Citation

Van 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Need for Endotracheal Ventilation in the First 72 hs of Life number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life first 72 hs of life No
Primary Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit first 3 days of life(72hours) No
Secondary Bronchopulmonary Dysplasia The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit. at 36 weeks gestational age No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Suspended NCT01852916 - NHFOV Versus NCPAP to Prevent Exubation Failure N/A
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Recruiting NCT03510169 - Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe N/A
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Completed NCT05038514 - The Effect of Music Therapy in COVID-19 Patients Given Prone Position N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Active, not recruiting NCT03808402 - The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Completed NCT01812681 - Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities N/A
Not yet recruiting NCT01440868 - Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome N/A
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Completed NCT01222247 - Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Phase 3