NCT03289936

Brief Summary

Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns (gestational age at birth \< 32 weeks) at their first approach to non invasive ventilation as first intention (soon after birth) or after extubation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3.2 years until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

September 18, 2017

Last Update Submit

November 27, 2023

Conditions

Newborn Respiratory DistressPreterm Infant

Keywords

pretermventilationnasal intermittent positive pressure ventilationsynchronizationcardio-respiratory eventsnewborn

Outcome Measures

Primary Outcomes (1)

  • Frequency of episodes of desaturation

    Desaturation is defined as a blood oxygen saturation below 80% for 4 sec. or more

    3 hours of NIPPV vs 3 hours SNIPPV

Secondary Outcomes (6)

  • Number of cardiorespiratory events

    3 hours of NIPPV vs 3 hours SNIPPV

  • O2 needing during SNIPPV vs NIPPV monitoring to maintain SatO2 TC between 90 and 94%

    3 hours of NIPPV vs 3 hours SNIPPV

  • Newborn pain score evaluation during SNIPPV vs NIPPV monitoring.

    3 hours of NIPPV vs 3 hours SNIPPV

  • Synchronization index

    3 hours of NIPPV vs 3 hours SNIPPV

  • Patient-ventilator concordance

    3 hours of NIPPV vs 3 hours SNIPPV

  • +1 more secondary outcomes

Study Arms (2)

Start ventilation with NIPPV

EXPERIMENTAL

Alternatively vented with NIPPV and SNIPPV

Device: NIPPVDevice: SNIPPV

Start ventilation with SNIPPV

EXPERIMENTAL

Alternatively vented with SNIPPV and NIPPV

Device: NIPPVDevice: SNIPPV

Interventions

NIPPVDEVICE

Non invasive ventilation technique in which PIP and PEEP administration is not synchronized with newborn's respiratory efforts

Start ventilation with NIPPVStart ventilation with SNIPPV
SNIPPVDEVICE

Non invasive ventilation technique in which PIP and PEEP administration is synchronized with newborn's respiratory efforts through an algorithm based on flow detection

Start ventilation with NIPPVStart ventilation with SNIPPV

Eligibility Criteria

AgeUp to 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age at birth \<32 weeks
  • First approach to NIV ventilation (primary or after extubation)
  • Parent's informed consent

You may not qualify if:

  • Neurological (including IVH \> 2° grade) or surgical diseases
  • Sepsis (clinical or laboratory confirmed)
  • Chromosomal or genetic abnormalities
  • Major malformations and congenital anomalies
  • Cardiac problems (including hemodynamically significant PDA)
  • Contraindication to NIV (i.e. nasal trauma and gastrointestinal surgery within the previous 7 days).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale S.Anna di Torino

Torino, (TO), 10126, Italy

RECRUITING

Related Publications (21)

  • Moretti C, Giannini L, Fassi C, Gizzi C, Papoff P, Colarizi P. Nasal flow-synchronized intermittent positive pressure ventilation to facilitate weaning in very low-birthweight infants: unmasked randomized controlled trial. Pediatr Int. 2008 Feb;50(1):85-91. doi: 10.1111/j.1442-200X.2007.02525.x.

    PMID: 18279212BACKGROUND

  • 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.

    PMID: 25318667BACKGROUND

  • Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.

    PMID: 30974433BACKGROUND

  • Cummings JJ, Polin RA; Committee on Fetus and Newborn, American Academy of Pediatrics. Noninvasive Respiratory Support. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3758. Epub 2015 Dec 29.

    PMID: 26715607BACKGROUND

  • 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.

    PMID: 27532916BACKGROUND

  • 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.

    PMID: 26922562BACKGROUND

  • Permall DL, Pasha AB, Chen XQ. Current insights in non-invasive ventilation for the treatment of neonatal respiratory disease. Ital J Pediatr. 2019 Aug 19;45(1):105. doi: 10.1186/s13052-019-0707-x.

    PMID: 31426828BACKGROUND

  • Ferguson KN, Roberts CT, Manley BJ, Davis PG. Interventions to Improve Rates of Successful Extubation in Preterm Infants: A Systematic Review and Meta-analysis. JAMA Pediatr. 2017 Feb 1;171(2):165-174. doi: 10.1001/jamapediatrics.2016.3015.

    PMID: 27918754BACKGROUND

  • 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.

    PMID: 28146296BACKGROUND

  • 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.

    PMID: 27251453BACKGROUND

  • Charles E, Hunt KA, Rafferty GF, Peacock JL, Greenough A. Work of breathing during HHHFNC and synchronised NIPPV following extubation. Eur J Pediatr. 2019 Jan;178(1):105-110. doi: 10.1007/s00431-018-3254-3. Epub 2018 Oct 30.

    PMID: 30374754BACKGROUND

  • Salvo V, Lista G, Lupo E, Ricotti A, Zimmermann LJ, Gavilanes AW, Barberi I, Colivicchi M, Temporini F, Gazzolo D. Noninvasive ventilation strategies for early treatment of RDS in preterm infants: an RCT. Pediatrics. 2015 Mar;135(3):444-51. doi: 10.1542/peds.2014-0895. Epub 2015 Feb 9.

    PMID: 25667244BACKGROUND

  • Manley BJ, Doyle LW, Owen LS, Davis PG. Extubating Extremely Preterm Infants: Predictors of Success and Outcomes following Failure. J Pediatr. 2016 Jun;173:45-9. doi: 10.1016/j.jpeds.2016.02.016. Epub 2016 Mar 5.

    PMID: 26960919BACKGROUND

  • Alexiou S, Panitch HB. Physiology of non-invasive respiratory support. Semin Fetal Neonatal Med. 2016 Jun;21(3):174-80. doi: 10.1016/j.siny.2016.02.007. Epub 2016 Feb 28.

    PMID: 26923501BACKGROUND

  • 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.

    PMID: 25418007BACKGROUND

  • Handoka NM, Azzam M, Gobarah A. Predictors of early synchronized non-invasive ventilation failure for infants < 32 weeks of gestational age with respiratory distress syndrome. Arch Med Sci. 2019 May;15(3):680-687. doi: 10.5114/aoms.2019.83040. Epub 2019 Feb 18.

    PMID: 31110534BACKGROUND

  • Aghai ZH, Saslow JG, Nakhla T, Milcarek B, Hart J, Lawrysh-Plunkett R, Stahl G, Habib RH, Pyon KH. Synchronized nasal intermittent positive pressure ventilation (SNIPPV) decreases work of breathing (WOB) in premature infants with respiratory distress syndrome (RDS) compared to nasal continuous positive airway pressure (NCPAP). Pediatr Pulmonol. 2006 Sep;41(9):875-81. doi: 10.1002/ppul.20461.

    PMID: 16850439BACKGROUND

  • 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.

    PMID: 26107742BACKGROUND

  • 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: 22954265BACKGROUND

  • Gizzi C, Papoff P, Giordano I, Massenzi L, Barbara CS, Campelli M, Panetta V, Agostino R, Moretti C. Flow-synchronized nasal intermittent positive pressure ventilation for infants <32 weeks' gestation with respiratory distress syndrome. Crit Care Res Pract. 2012;2012:301818. doi: 10.1155/2012/301818. Epub 2012 Nov 27.

    PMID: 23227317BACKGROUND

  • Cresi F, Chiale F, Maggiora E, Borgione SM, Ferroglio M, Runfola F, Maiocco G, Peila C, Bertino E, Coscia A. Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial. Trials. 2021 Jun 14;22(1):392. doi: 10.1186/s13063-021-05351-0.

    PMID: 34127040DERIVED

MeSH Terms

Conditions

Hyaline Membrane DiseasePremature BirthRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Cresi, PhD

    Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

    STUDY CHAIR

  • Alessandra Coscia, Prof.

    Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

    STUDY DIRECTOR

  • Elena Maggiora, MD

    Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Cresi, PhD, MD

CONTACT

+39 11 3135781francesco.cresi@unito.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 21, 2017

Study Start

November 16, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

IT(1)