Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

NCT02396693 | Completed DMC

• 1 other identifier: FUMinasGerais
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were included in this study in three groups , group 1: Nasal Intermittent Positive Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator (NCPAP ventilator) (n=32)

Conditions

Respiratory Distress Syndrome In Premature Infants

Keywords

Newborn; non invasive ventilation

Outcome Measures

Primary Outcomes (1)

• The success rate of the extubation

  The success rate of the extubation and Need for intubation within the first 48 hours after extubation in the three groups

  Finished The newborns were followed for all interaction until discharge (about 5 weeks).

Secondary Outcomes (4)

• Correlations of the noninvasive support (correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP)

  Finished The newborns were followed for all interaction until discharge (about 5 weeks).

• The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)

  Finished The newborns were followed for all interaction until discharge (about 5 weeks).

• Incidence of the diseases during the hospitalization

  Finished The newborns were followed for all interaction until discharge (about 5 weeks).

• Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)

  Finished The newborns were followed for all interaction until discharge (about 5 weeks).

Study Arms (3)

NIPPV

EXPERIMENTAL

NIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator.

Device: NIPPV

Bubble NCPAP

PLACEBO COMPARATOR

Bubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP.

Device: Bubble NCPAP

Ventilator NCPAP

PLACEBO COMPARATOR

Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator.

Device: Ventilator NCPAP

Interventions

NIPPV DEVICE

Ventilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) \< 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) \< 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease)

Also known as: Non invasive ventilation

NIPPV

Bubble NCPAP DEVICE

Bubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble.

Bubble NCPAP

Ventilator NCPAP DEVICE

Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min).

Ventilator NCPAP

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Were eligible for the study
• Newborn (NB) ≤ 34 weeks and 500g to the weight of ≤ 1500 grams with a diagnosis of respiratory distress syndrome (RDS) who had their first elective extubation.

You may not qualify if:

• Excluded patients with cardiorespiratory system malformations
• Genetic disorders
• Neuromuscular disease and malformations of the central nervous system.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (8)

• 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

• Mehta P, Berger J, Bucholz E, Bhandari V. Factors affecting nasal intermittent positive pressure ventilation failure and impact on bronchopulmonary dysplasia in neonates. J Perinatol. 2014 Oct;34(10):754-60. doi: 10.1038/jp.2014.100. Epub 2014 May 29.

  PMID: 24875408 RESULT

• Bhandari V. Noninvasive respiratory support in the preterm infant. Clin Perinatol. 2012 Sep;39(3):497-511. doi: 10.1016/j.clp.2012.06.008.

  PMID: 22954265 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

• Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.

  PMID: 23944299 RESULT

• Khorana M, Paradeevisut H, Sangtawesin V, Kanjanapatanakul W, Chotigeat U, Ayutthaya JK. A randomized trial of non-synchronized Nasopharyngeal Intermittent Mandatory Ventilation (nsNIMV) vs. Nasal Continuous Positive Airway Pressure (NCPAP) in the prevention of extubation failure in pre-term < 1,500 grams. J Med Assoc Thai. 2008 Oct;91 Suppl 3:S136-42.

  PMID: 19253509 RESULT

• Bahman-Bijari B, Malekiyan A, Niknafs P, Baneshi MR. Bubble-CPAP vs. Ventilatory-CPAP in Preterm Infants with Respiratory Distress. Iran J Pediatr. 2011 Jun;21(2):151-8.

  PMID: 23056781 RESULT

• Kumar M, Avasthi S, Ahuja S, Malik GK, Singh SN. Unsynchronized Nasal Intermittent Positive Pressure Ventilation to prevent extubation failure in neonates: a randomized controlled trial. Indian J Pediatr. 2011 Jul;78(7):801-6. doi: 10.1007/s12098-010-0357-x. Epub 2011 Feb 2.

  PMID: 21287368 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Cíntia Johnston

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: March 24, 2015
• Study Start: August 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 3, 2016

Record last verified: 2016-02