nHFOV Versus nCPAP in Transient Tachypnea of the Newborn

NCT03006354 | Completed

• 1 other identifier: 2011-KAEK-25 2016/22-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants with transient tachypnea of the newborn requiring non-invasive ventilation.

Conditions

Transient Tachypnea of the Newborn

Keywords

high frequency oscillatory ventilation; newborn; noninvasive ventilation; transient tachypnea of the newborn

Outcome Measures

Primary Outcomes (1)

• Time to cessation of non-invasive positive pressure respiratory support

  Cessation of nasal flaring, grunting and chest wall retractions (Silverman Score of 0) are indicators of readiness for discontinuation non-invasive positive pressure respiratory support.

  72 hours

Secondary Outcomes (2)

• Time to cessation of supplemental oxygen

  120 hours

• Time to discharge from hospital

  120 hours

Other Outcomes (1)

• Pneumothorax

  72 hours

Study Arms (2)

nHFOV

EXPERIMENTAL

Ventilator-derived nHFOV will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nHFOV settings are: MAP: 8cmH2O, Frequency:10 MHz, Amplitude:35 cmH2O (will be adjusted to achieve adequate chest wall vibration), I:E=1:1 and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure is defined as FiO2 requirement of \>%60, capillary blood gas obtained at the 4th hour of therapy showing pH\<7.20 or pCO2\>65 cmH2O. When nHFOV failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95.

Device: nHFOV

nCPAP

ACTIVE COMPARATOR

Ventilator-derived nCPAP will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure is defined as FiO2 requirement of \>%60, capillary blood gas obtained at the 4th hour of therapy showing pH\<7.20 or pCO2\>65 cmH2O. When nCPAP failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95.

Device: nCPAP

Interventions

nHFOV DEVICE

Ventilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs

Also known as: nasal high frequency oscillatory ventilation

nHFOV

nCPAP DEVICE

Ventilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs

Also known as: nasal continuous positive airway pressure

nCPAP

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age at birth between 34 and 42 weeks of gestation
• Admission to Bursa Yüksek Ihtisas Teaching Hospital, NICU during the first 24 hours of life
• Diagnosis of transient tachypnea of the newborn (TTN) within the first 24 hours of life

You may not qualify if:

• Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
• Chest X-ray or lung ultrasound finding indicating another respiratory disorder
• Additional infant diagnosis of major cardiac disease
• Additional infant diagnosis of major pulmonary disease other than TTN
• Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period
• Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

University of Health Sciences, Bursa Yuksek Ihtisas Teaching Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (3)

• Fischer HS, Bohlin K, Buhrer C, Schmalisch G, Cremer M, Reiss I, Czernik C. Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep 18.

  PMID: 25227281 RESULT

• De Luca D, Dell'Orto V. Non-invasive high-frequency oscillatory ventilation in neonates: review of physiology, biology and clinical data. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F565-F570. doi: 10.1136/archdischild-2016-310664. Epub 2016 Jun 28.

  PMID: 27354382 RESULT

• Baldan E, Varal IG, Dogan P, Cizmeci MN. The effect of non-invasive high-frequency oscillatory ventilation on the duration of non-invasive respiratory support in late preterm and term infants with transient tachypnea of the newborn: a randomized controlled trial. Eur J Pediatr. 2023 Oct;182(10):4499-4507. doi: 10.1007/s00431-023-05128-4. Epub 2023 Jul 26.

  PMID: 37491619 DERIVED

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mehmet N Cizmeci, M.D

  Bursa Yuksek Ihtisas Teaching Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: December 30, 2016
• Study Start: February 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2018
• Last Updated: December 6, 2023

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)