Respiratory Distress Syndrome of NewbornNCT03989960

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

A study testing LISA+SNIPPV and traditional InSurE in people with Respiratory Distress Syndrome of Newborn, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages Up to 1 year
Conditions the study is for: Respiratory Distress Syndrome of Newborn
What is being tested?: LISA+SNIPPV and traditional InSurE
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Aug 2018to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029

Other trials in China

About this study

Official title: Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

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.

Conditions: Respiratory Distress Syndrome of Newborn
Being tested: LISA+SNIPPV, traditional InSurE
Keywords: InSurE, LISA, SNIPPV
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LISA+SNIPPVProcedure or surgery
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
traditional InSurEProcedure or surgery
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.

Study groups in NCT03989960
Study group	Role	What they receive
LISA+SNIPPV group	Experimental	receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation Receives: Procedure: LISA+SNIPPV
InSurE group	Active comparator	receives intubation-surfactant- extubation technique and selects CPAP ventilation Receives: Procedure: traditional InSurE

What is being measured

The primary outcome is the main question the study is designed to answer.

the average duration of mechanical ventilation
the average duration of mechanical ventilation of each group
Measured: 40 weeks
the duration of oxygen therapy
the duration of oxygen therapy of each group
Measured: 40 weeks
the incidence of BPD
the incidence of BPD in each group
Measured: 28 days

Secondary outcomes (3)

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.
Measured: 1st, 2nd, 3rd, 7th, 14th, 28th days
the incidence of complications
the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)
Measured: 40 weeks
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Measured: the period of oxygen therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201831 Dec 2019

First posted18 Jun 2019
Study start1 Aug 2018
Primary completion31 Dec 2019 (estimated)
Study completion31 Dec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Respiratory Distress Syndrome of NewbornStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03989960
Sponsor's protocol ID: MOLISAN
Status last verified: Jun 2019
First submitted: 17 Jun 2019
Last updated: 21 Jun 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 27649091
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.
PubMed 25607427
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.
PubMed 23612264
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.
PubMed 20439601
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.
PubMed 25474712
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.
PubMed 20084586
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.
PubMed 21963186
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.
PubMed 28538236
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.
PubMed 26053341
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.
PubMed 23359581
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.
PubMed 25089718
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.
PubMed 28152280
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.
PubMed 27942865
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.
PubMed 27992064
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.
PubMed 27852668

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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All Respiratory Distress Syndrome of Newborn trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT03989960
Acronym / sponsor ID: MOLISAN
Conditions: Respiratory Distress Syndrome of Newborn
Keywords: InSurE, LISA, SNIPPV
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 1 Aug 2018 (actual)
Primary completion: 31 Dec 2019 (estimated)
Study completion: 31 Dec 2019 (estimated)
First posted: 18 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LISA+SNIPPV group	Experimental	Procedure: LISA+SNIPPVreceives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
InSurE group	Active comparator	Procedure: traditional InSurEreceives intubation-surfactant- extubation technique and selects CPAP ventilation

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LISA+SNIPPVThe LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.	Procedure or surgery	LISA+SNIPPV group
traditional InSurEThe traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.	Procedure or surgery	InSurE group

Primary outcome

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

3 secondary outcomes

Pulmonary Severity Score (PSC)
Time frame: 1st, 2nd, 3rd, 7th, 14th, 28th days
the incidence of complications
Time frame: 40 weeks
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Time frame: the period of oxygen therapy

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
Background: PubMed 27649091Sweet 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.
Background: PubMed 25607427Patel 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.
Background: PubMed 23612264Leone 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.
Background: PubMed 20439601Sandri 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.
Background: PubMed 25474712Gopel 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.
Background: PubMed 20084586Kribs 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.
Background: PubMed 21963186Gopel 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.
Background: PubMed 28538236Niemarkt 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.
Background: PubMed 26053341Kribs 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.
Background: PubMed 23359581Kanmaz 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.
Background: PubMed 25089718More 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.
Background: PubMed 28152280Wu 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.
Individual participant dataSharing planned: No

Related trials for Respiratory Distress Syndrome of Newborn

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoqing Chen, Dr study director

The First Affiliated Hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LISA+SNIPPV and traditional InSurE in people with Respiratory Distress Syndrome of Newborn, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the average duration of mechanical ventilation (time frame: 40 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989960, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.