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出境医 / 临床实验 / Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

Study Description
Brief Summary:
This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome of Newborn Procedure: LISA+SNIPPV Procedure: traditional InSurE Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: LISA+SNIPPV group
receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
 Procedure: LISA+SNIPPV
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
Active Comparator: InSurE group
receives intubation-surfactant- extubation technique and selects CPAP ventilation
 Procedure: traditional InSurE
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Outcome Measures
Primary Outcome Measures :
  1. the average duration of mechanical ventilation [ Time Frame: 40 weeks ]
    the average duration of mechanical ventilation of each group

  2. the duration of oxygen therapy [ Time Frame: 40 weeks ]
    the duration of oxygen therapy of each group

  3. the incidence of BPD [ Time Frame: 28 days ]
    the incidence of BPD in each group


Secondary Outcome Measures :
  1. Pulmonary Severity Score (PSC) [ Time Frame: 1st, 2nd, 3rd, 7th, 14th, 28th days ]
    PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95.

  2. the incidence of complications [ Time Frame: 40 weeks ]
    the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)

  3. oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) [ Time Frame: the period of oxygen therapy ]
    oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. premature infants with birth weight < 2500g and gestational age < 36+6 weeks;
  2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
  3. the participating hospital obtained the consent of the Ethics Committee.
  4. parental informed consents were obtained.

Exclusion Criteria:

  1. severe congenital malformations.
  2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
  3. congenital hereditary metabolic diseases.
  4. parental informed consent was not obtained.
Contacts and Locations

Locations
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China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Layout table for investigator information
Study Director: Xiaoqing Chen, Dr The First Affiliated Hospital with Nanjing Medical University
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • the average duration of mechanical ventilation [ Time Frame: 40 weeks ]
    the average duration of mechanical ventilation of each group
  • the duration of oxygen therapy [ Time Frame: 40 weeks ]
    the duration of oxygen therapy of each group
  • the incidence of BPD [ Time Frame: 28 days ]
    the incidence of BPD in each group
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • mechanical ventilation [ Time Frame: 40 weeks ]
    the average duration of mechanical ventilation
  • oxygen therapy [ Time Frame: 40 weeks ]
    the duration of oxygen therapy
  • the incidence of BPD [ Time Frame: 28 days ]
    the incidence of BPD in each group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Pulmonary Severity Score (PSC) [ Time Frame: 1st, 2nd, 3rd, 7th, 14th, 28th days ]
    PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95.
  • the incidence of complications [ Time Frame: 40 weeks ]
    the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)
  • oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) [ Time Frame: the period of oxygen therapy ]
    oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		Pulmonary Severity Score [ Time Frame: 1st, 2nd, 3rd, 7th, 14th, 28th days ]
PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Official Title  ICMJE Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Brief Summary This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome of Newborn
Intervention  ICMJE
  • Procedure: LISA+SNIPPV
    The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
  • Procedure: traditional InSurE
    The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Study Arms  ICMJE
  • Experimental: LISA+SNIPPV group
    receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
    Intervention: Procedure: LISA+SNIPPV
  • Active Comparator: InSurE group
    receives intubation-surfactant- extubation technique and selects CPAP ventilation
    Intervention: Procedure: traditional InSurE
Publications *
  • Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
  • Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sánchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.
  • Leone F, Trevisanuto D, Cavallin F, Parotto M, Zanardo V. Efficacy of INSURE during nasal CPAP in preterm infants with respiratory distress syndrome. Minerva Pediatr. 2013 Apr;65(2):187-92.
  • Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.
  • Göpel W, Kribs A, Härtel C, Avenarius S, Teig N, Groneck P, Olbertz D, Roll C, Vochem M, Weller U, von der Wense A, Wieg C, Wintgens J, Preuss M, Ziegler A, Roth B, Herting E; German Neonatal Network (GNN). Less invasive surfactant administration is associated with improved pulmonary outcomes in spontaneously breathing preterm infants. Acta Paediatr. 2015 Mar;104(3):241-6. doi: 10.1111/apa.12883.
  • Kribs A, Härtel C, Kattner E, Vochem M, Küster H, Möller J, Müller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Göpel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.
  • Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Siegel J, Avenarius S, von der Wense A, Vochem M, Groneck P, Weller U, Möller J, Härtel C, Haller S, Roth B, Herting E; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011 Nov 5;378(9803):1627-34. doi: 10.1016/S0140-6736(11)60986-0. Epub 2011 Sep 29.
  • Niemarkt HJ, Hütten MC, Kramer BW. Surfactant for Respiratory Distress Syndrome: New Ideas on a Familiar Drug with Innovative Applications. Neonatology. 2017;111(4):408-414. doi: 10.1159/000458466. Epub 2017 May 25. Review.
  • Kribs A, Roll C, Göpel W, Wieg C, Groneck P, Laux R, Teig N, Hoehn T, Böhm W, Welzing L, Vochem M, Hoppenz M, Bührer C, Mehler K, Stützer H, Franklin J, Stöhr A, Herting E, Roth B; NINSAPP Trial Investigators. Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):723-30. doi: 10.1001/jamapediatrics.2015.0504.
  • Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013 Feb;131(2):e502-9. doi: 10.1542/peds.2012-0603. Epub 2013 Jan 28.
  • More K, Sakhuja P, Shah PS. Minimally invasive surfactant administration in preterm infants: a meta-narrative review. JAMA Pediatr. 2014 Oct;168(10):901-8. doi: 10.1001/jamapediatrics.2014.1148. Review.
  • Wu W, Shi Y, Li F, Wen Z, Liu H. Surfactant administration via a thin endotracheal catheter during spontaneous breathing in preterm infants. Pediatr Pulmonol. 2017 Jun;52(6):844-854. doi: 10.1002/ppul.23651. Epub 2017 Feb 2. Review.
  • Klotz D, Porcaro U, Fleck T, Fuchs H. European perspective on less invasive surfactant administration-a survey. Eur J Pediatr. 2017 Feb;176(2):147-154. doi: 10.1007/s00431-016-2812-9. Epub 2016 Dec 9.
  • Heiring C, Jonsson B, Andersson S, Björklund LJ. Survey shows large differences between the Nordic countries in the use of less invasive surfactant administration. Acta Paediatr. 2017 Mar;106(3):382-386. doi: 10.1111/apa.13694. Epub 2017 Jan 4.
  • Aldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant administration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F17-F23. doi: 10.1136/archdischild-2015-310299. Epub 2016 Nov 15. Review.
  • Rigo V, Lefebvre C, Broux I. Surfactant instillation in spontaneously breathing preterm infants: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1933-1942. Epub 2016 Sep 27. Review.
  • Keszler M, Sant'Anna G. Mechanical Ventilation and Bronchopulmonary Dysplasia. Clin Perinatol. 2015 Dec;42(4):781-96. doi: 10.1016/j.clp.2015.08.006. Epub 2015 Oct 1. Review.
  • 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.
  • Ramos-Navarro C, Sanchez-Luna M, Sanz-López E, Maderuelo-Rodriguez E, Zamora-Flores E. Effectiveness of Synchronized Noninvasive Ventilation to Prevent Intubation in Preterm Infants. AJP Rep. 2016 Jul;6(3):e264-71. doi: 10.1055/s-0036-1586205.
  • Moretti C, Gizzi C, Montecchia F, Barbàra CS, Midulla F, Sanchez-Luna M, Papoff P. Synchronized Nasal Intermittent Positive Pressure Ventilation of the Newborn: Technical Issues and Clinical Results. Neonatology. 2016;109(4):359-65. doi: 10.1159/000444898. Epub 2016 Jun 3. Review.
  • Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016 Dec 15;12:CD005384. doi: 10.1002/14651858.CD005384.pub2. Review.
  • Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.
  • Li W, Long C, Zhangxue H, Jinning Z, Shifang T, Juan M, Renjun L, Yuan S. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome: a meta-analysis and up-date. Pediatr Pulmonol. 2015 Apr;50(4):402-9. doi: 10.1002/ppul.23130. Epub 2014 Nov 21. Review.
  • Isayama T, Iwami H, McDonald S, Beyene J. Association of Noninvasive Ventilation Strategies With Mortality and Bronchopulmonary Dysplasia Among Preterm Infants: A Systematic Review and Meta-analysis. JAMA. 2016 Aug 9;316(6):611-24. doi: 10.1001/jama.2016.10708. Review. Erratum in: JAMA. 2016 Sep 13;316(10):1116.
  • Owen LS, Manley BJ. Nasal intermittent positive pressure ventilation in preterm infants: Equipment, evidence, and synchronization. Semin Fetal Neonatal Med. 2016 Jun;21(3):146-53. doi: 10.1016/j.siny.2016.01.003. Epub 2016 Feb 26. Review.
  • Lemyre 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:CD003212. doi: 10.1002/14651858.CD003212.pub3. Review.
  • Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.
  • Gizzi C, Montecchia F, Panetta V, Castellano C, Mariani C, Campelli M, Papoff P, Moretti C, Agostino R. Is synchronised NIPPV more effective than NIPPV and NCPAP in treating apnoea of prematurity (AOP)? A randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F17-23. doi: 10.1136/archdischild-2013-305892. Epub 2014 Oct 15.
  • Huang L, Mendler MR, Waitz M, Schmid M, Hassan MA, Hummler HD. Effects of Synchronization during Noninvasive Intermittent Mandatory Ventilation in Preterm Infants with Respiratory Distress Syndrome Immediately after Extubation. Neonatology. 2015;108(2):108-14. doi: 10.1159/000431074. Epub 2015 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. premature infants with birth weight < 2500g and gestational age < 36+6 weeks;
  2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
  3. the participating hospital obtained the consent of the Ethics Committee.
  4. parental informed consents were obtained.

Exclusion Criteria:

  1. severe congenital malformations.
  2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
  3. congenital hereditary metabolic diseases.
  4. parental informed consent was not obtained.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989960
Other Study ID Numbers  ICMJE MOLISAN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xiaoqing Chen, Dr The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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