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

Primary Purpose

Respiratory Distress Syndrome of Newborn

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LISA+SNIPPV
traditional InSurE
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome of Newborn focused on measuring InSurE, LISA, SNIPPV

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LISA+SNIPPV group

InSurE group

Arm Description

receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation

receives intubation-surfactant- extubation technique and selects CPAP ventilation

Outcomes

Primary Outcome Measures

the average duration of mechanical ventilation
the average duration of mechanical ventilation of each group
the duration of oxygen therapy
the duration of oxygen therapy of each group
the incidence of BPD
the incidence of BPD in each group

Secondary Outcome Measures

Pulmonary Severity Score (PSC)
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
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)
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)

Full Information

First Posted
June 17, 2019
Last Updated
June 19, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03989960
Brief Title
Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Official Title
Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome of Newborn
Keywords
InSurE, LISA, SNIPPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LISA+SNIPPV group
Arm Type
Experimental
Arm Description
receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
Arm Title
InSurE group
Arm Type
Active Comparator
Arm Description
receives intubation-surfactant- extubation technique and selects CPAP ventilation
Intervention Type
Procedure
Intervention Name(s)
LISA+SNIPPV
Intervention Description
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
Intervention Type
Procedure
Intervention Name(s)
traditional InSurE
Intervention Description
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Primary Outcome Measure Information:
Title
the average duration of mechanical ventilation
Description
the average duration of mechanical ventilation of each group
Time Frame
40 weeks
Title
the duration of oxygen therapy
Description
the duration of oxygen therapy of each group
Time Frame
40 weeks
Title
the incidence of BPD
Description
the incidence of BPD in each group
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Pulmonary Severity Score (PSC)
Description
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.
Time Frame
1st, 2nd, 3rd, 7th, 14th, 28th days
Title
the incidence of complications
Description
the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)
Time Frame
40 weeks
Title
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Description
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Time Frame
the period of oxygen therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: premature infants with birth weight < 2500g and gestational age < 36+6 weeks; High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS. the participating hospital obtained the consent of the Ethics Committee. parental informed consents were obtained. Exclusion Criteria: severe congenital malformations. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics. congenital hereditary metabolic diseases. parental informed consent was not obtained.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqing Chen, Dr
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27649091
Citation
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.
Results Reference
background
PubMed Identifier
25607427
Citation
Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez 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.
Results Reference
background
PubMed Identifier
23612264
Citation
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.
Results Reference
background
PubMed Identifier
20439601
Citation
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.
Results Reference
background
PubMed Identifier
25474712
Citation
Gopel W, Kribs A, Hartel 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.
Results Reference
background
PubMed Identifier
20084586
Citation
Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel 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.
Results Reference
background
PubMed Identifier
21963186
Citation
Gopel 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, Moller J, Hartel 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.
Results Reference
background
PubMed Identifier
28538236
Citation
Niemarkt HJ, Hutten 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.
Results Reference
background
PubMed Identifier
26053341
Citation
Kribs A, Roll C, Gopel W, Wieg C, Groneck P, Laux R, Teig N, Hoehn T, Bohm W, Welzing L, Vochem M, Hoppenz M, Buhrer C, Mehler K, Stutzer H, Franklin J, Stohr 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.
Results Reference
background
PubMed Identifier
23359581
Citation
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.
Results Reference
background
PubMed Identifier
25089718
Citation
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.
Results Reference
background
PubMed Identifier
28152280
Citation
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.
Results Reference
background
PubMed Identifier
27942865
Citation
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.
Results Reference
background
PubMed Identifier
27992064
Citation
Heiring C, Jonsson B, Andersson S, Bjorklund 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.
Results Reference
background
PubMed Identifier
27852668
Citation
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.
Results Reference
background
PubMed Identifier
27678511
Citation
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. doi: 10.1007/s00431-016-2789-4. Epub 2016 Sep 27.
Results Reference
background
PubMed Identifier
26593078
Citation
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.
Results Reference
background
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
background
PubMed Identifier
27500013
Citation
Ramos-Navarro C, Sanchez-Luna M, Sanz-Lopez 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.
Results Reference
background
PubMed Identifier
27251453
Citation
Moretti C, Gizzi C, Montecchia F, Barbara 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.
Results Reference
background
PubMed Identifier
27976361
Citation
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(12):CD005384. doi: 10.1002/14651858.CD005384.pub2.
Results Reference
background
PubMed Identifier
24039148
Citation
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.
Results Reference
background
PubMed Identifier
25418007
Citation
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.
Results Reference
background
PubMed Identifier
27532916
Citation
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. Erratum In: JAMA. 2016 Sep 13;316(10):1116.
Results Reference
background
PubMed Identifier
26922562
Citation
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.
Results Reference
background
PubMed Identifier
28146296
Citation
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(2):CD003212. doi: 10.1002/14651858.CD003212.pub3.
Results Reference
background
PubMed Identifier
26553376
Citation
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.
Results Reference
background
PubMed Identifier
25318667
Citation
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.
Results Reference
background
PubMed Identifier
26107742
Citation
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.
Results Reference
background

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

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