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Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

Primary Purpose

Respiratory Distress Syndrome In Premature Infants

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NIPPV
Bubble NCPAP
Ventilator NCPAP
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome In Premature Infants focused on measuring Newborn, non invasive ventilation

Eligibility Criteria

26 Weeks - 34 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    NIPPV

    Bubble NCPAP

    Ventilator NCPAP

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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)
    Related to noninvasive support and correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP).
    The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
    The failure vs. success, with the days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
    Incidence of the diseases during the hospitalization
    Incidence of pneumothorax, patent ductus arterious (PDA), retinopathy of prematurity (HOP), peri-intraventricular hemorrhage (HPIV), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), nasal injury
    Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)
    Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    February 2, 2016
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02396693
    Brief Title
    Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms
    Official Title
    Successful Extubation and Noninvasive Ventilation in Preterm Infants ≤ 1500g Terms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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)
    Detailed Description
    The infants were randomly allocated after extubation used a list of computer-generated randomization in NIPPV modes (with the following settings: positive inspiratory pressure (PIP) < 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5 centimeters of water (cm H2O, backup respiratory rate (RR) < 18 cycles per minute flow 6-7 liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5 centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was adjusted to maintain arterial oxygen saturation between 85-95% The criteria for extubation were defined using a protocol by the clinic staff, confirmed by arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings. Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately, 15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented. Neonatal morbidities were documented until discharge, among these are: patent ductus arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and pneumothorax. Data on achievement of prenatal, antenatal steroids and surfactant administration were documented. All newborns were natural porcine surfactant Curosurf®. The total duration of mechanical ventilation and oxygen were documented from birth until discharge or death. The supplemental oxygen or mechanical ventilation days was defined as daily requirement of fraction of inspired oxygen (FiO 2)> 0.21 or ventilation > 12 hours, respectively. The newborns were followed for all interaction until discharge (about 5 weeks).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Distress Syndrome In Premature Infants
    Keywords
    Newborn, non invasive ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NIPPV
    Arm Type
    Experimental
    Arm Description
    NIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator.
    Arm Title
    Bubble NCPAP
    Arm Type
    Placebo Comparator
    Arm Description
    Bubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP.
    Arm Title
    Ventilator NCPAP
    Arm Type
    Placebo Comparator
    Arm Description
    Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator.
    Intervention Type
    Device
    Intervention Name(s)
    NIPPV
    Other Intervention Name(s)
    Non invasive ventilation
    Intervention Description
    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)
    Intervention Type
    Device
    Intervention Name(s)
    Bubble NCPAP
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Ventilator NCPAP
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    The success rate of the extubation
    Description
    The success rate of the extubation and Need for intubation within the first 48 hours after extubation in the three groups
    Time Frame
    Finished The newborns were followed for all interaction until discharge (about 5 weeks).
    Secondary Outcome Measure Information:
    Title
    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)
    Description
    Related to noninvasive support and correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP).
    Time Frame
    Finished The newborns were followed for all interaction until discharge (about 5 weeks).
    Title
    The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
    Description
    The failure vs. success, with the days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
    Time Frame
    Finished The newborns were followed for all interaction until discharge (about 5 weeks).
    Title
    Incidence of the diseases during the hospitalization
    Description
    Incidence of pneumothorax, patent ductus arterious (PDA), retinopathy of prematurity (HOP), peri-intraventricular hemorrhage (HPIV), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), nasal injury
    Time Frame
    Finished The newborns were followed for all interaction until discharge (about 5 weeks).
    Title
    Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)
    Description
    Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration
    Time Frame
    Finished The newborns were followed for all interaction until discharge (about 5 weeks).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Weeks
    Maximum Age & Unit of Time
    34 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Excluded patients with cardiorespiratory system malformations Genetic disorders Neuromuscular disease and malformations of the central nervous system.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cíntia Johnston
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26135774
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24875408
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22954265
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22474063
    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 Apr;166(4):372-6. doi: 10.1001/archpediatrics.2011.1142.
    Results Reference
    result
    PubMed Identifier
    23944299
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19253509
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23056781
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21287368
    Citation
    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. Erratum In: Indian J Pediatr. 2011 Nov;78(11):1434.
    Results Reference
    result

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    Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

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