Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

NCT ID: NCT04404816

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

Brief Summary

The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

Detailed Description

Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.

Conditions

Respiratory Distress Syndrome; Premature Infants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

premature infants born \< 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 \<0.4

Group Type: EXPERIMENTAL

heliox

Intervention Type: DRUG

NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.

Group 2

premature infants born \< 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt

Group Type: EXPERIMENTAL

heliox

Intervention Type: DRUG

NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.

Interventions

heliox

NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.

Intervention Type: DRUG

Other Intervention Names

helium-oxygen gas mixture

Eligibility Criteria

Inclusion Criteria

• GA under 33 weeks GA
• Need for NIV due to clinical symptoms of respiratory distress in course of RDS
• FiO2=0.25-0.4
• Enrollment within first 72 hours of life
• Parental consent

• GA under 33 weeks GA
• Need for MV due to clinical symptoms of respiratory distress
• at least one failed attempted extubation
• Parental consent

Exclusion Criteria

• Major congenital anomalies
• Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)

• Minimum Eligible Age: 1 Hour
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society for Paediatric Research

UNKNOWN

Sponsor Role: collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Szczapa

Deputy Head - Department of Neonatology; Head - Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Szczapa, M.D. PhD

Role: STUDY_DIRECTOR

Department of Neonatology - Poznan University of Medical Sciences

Locations

Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33

Poznan, Great Poland, Poland

Countries

Poland

References

Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.

Reference Type: BACKGROUND

PMID: 23736015 (View on PubMed)

Elleau C, Galperine RI, Guenard H, Demarquez JL. Helium-oxygen mixture in respiratory distress syndrome: a double-blind study. J Pediatr. 1993 Jan;122(1):132-6. doi: 10.1016/s0022-3476(05)83506-1.

Reference Type: BACKGROUND

PMID: 8419600 (View on PubMed)

Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.

Reference Type: BACKGROUND

PMID: 22291116 (View on PubMed)

Szczapa T, Gadzinowski J, Moczko J, Merritt TA. Heliox for mechanically ventilated newborns with bronchopulmonary dysplasia. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F128-33. doi: 10.1136/archdischild-2013-303988. Epub 2013 Nov 15.

Reference Type: BACKGROUND

PMID: 24239984 (View on PubMed)

Szczapa T, Gadzinowski J. Use of heliox in the management of neonates with meconium aspiration syndrome. Neonatology. 2011;100(3):265-70. doi: 10.1159/000327531. Epub 2011 Jun 23.

Reference Type: BACKGROUND

PMID: 21701217 (View on PubMed)

Jassar RK, Vellanki H, Zhu Y, Hesek A, Wang J, Rodriguez E, Wu J, Shaffer TH, Wolfson MR. High flow nasal cannula (HFNC) with Heliox decreases diaphragmatic injury in a newborn porcine lung injury model. Pediatr Pulmonol. 2014 Dec;49(12):1214-22. doi: 10.1002/ppul.23000. Epub 2014 Feb 5.

Reference Type: BACKGROUND

PMID: 24500982 (View on PubMed)

Sinderby C, Beck J, Spahija J, Weinberg J, Grassino A. Voluntary activation of the human diaphragm in health and disease. J Appl Physiol (1985). 1998 Dec;85(6):2146-58. doi: 10.1152/jappl.1998.85.6.2146.

Reference Type: BACKGROUND

PMID: 9843538 (View on PubMed)

Beck J, Reilly M, Grasselli G, Qui H, Slutsky AS, Dunn MS, Sinderby CA. Characterization of neural breathing pattern in spontaneously breathing preterm infants. Pediatr Res. 2011 Dec;70(6):607-13. doi: 10.1203/PDR.0b013e318232100e.

Reference Type: BACKGROUND

PMID: 21857389 (View on PubMed)

Brooks LJ, DiFiore JM, Martin RJ. Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Pediatr Pulmonol. 1997 Jun;23(6):429-33. doi: 10.1002/(sici)1099-0496(199706)23:63.0.co;2-d.

Reference Type: BACKGROUND

PMID: 9220525 (View on PubMed)

Nawab US, Touch SM, Irwin-Sherman T, Blackson TJ, Greenspan JS, Zhu G, Shaffer TH, Wolfson MR. Heliox attenuates lung inflammation and structural alterations in acute lung injury. Pediatr Pulmonol. 2005 Dec;40(6):524-32. doi: 10.1002/ppul.20304.

Reference Type: BACKGROUND

PMID: 16193495 (View on PubMed)

Kuligowski J, Escobar J, Quintas G, Lliso I, Torres-Cuevas I, Nunez A, Cubells E, Rook D, van Goudoever JB, Vento M. Analysis of lipid peroxidation biomarkers in extremely low gestational age neonate urines by UPLC-MS/MS. Anal Bioanal Chem. 2014 Jul;406(18):4345-56. doi: 10.1007/s00216-014-7824-6. Epub 2014 May 11.

Reference Type: BACKGROUND

PMID: 24817352 (View on PubMed)

Kuligowski J, Torres-Cuevas I, Quintas G, Rook D, van Goudoever JB, Cubells E, Asensi M, Lliso I, Nunez A, Vento M, Escobar J. Assessment of oxidative damage to proteins and DNA in urine of newborn infants by a validated UPLC-MS/MS approach. PLoS One. 2014 Apr 2;9(4):e93703. doi: 10.1371/journal.pone.0093703. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24695409 (View on PubMed)

Oei GT, Weber NC, Hollmann MW, Preckel B. Cellular effects of helium in different organs. Anesthesiology. 2010 Jun;112(6):1503-10. doi: 10.1097/ALN.0b013e3181d9cb5e.

Reference Type: BACKGROUND

PMID: 20460992 (View on PubMed)

Other Identifiers

072015

Identifier Type: -

Identifier Source: org_study_id