nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome

NCT04914715 | Withdrawn DMC

• 1 other identifier: 2021_01_09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non-invasive is relatively safe but non-invasive high frequency oscillatory ventilation (nHFOV) is not appropriately evaluated in neonates as primary support. So the investigators hypothesized that nHFOV is relatively safe and effective in comparison with invasive ventilation for preterm neonates with RDS.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

nHFOV; RDS; CPAP; Respiratory failure; Respiratory support

Outcome Measures

Primary Outcomes (3)

• Respiratory Support Escalation

  After starting with intervention or control group, baby will be monitored for further escalation of respiratory support like baby is Conventional Invasive Ventilation needs High frequency oscillatory ventilation. Baby started on NHFOV need invasive ventilation.

  within first 24 hours of intervention

• Oxygen Requirement

  With assigned intervention or comparator, baby will be monitored for oxygen requirement comparing with baseline oxygen demand or \> 40% of fractional Inspiratory oxygen.

  Within first 24 hours

• Weaning from Assigned respiratory support

  Babies started on intervention or comparator will be monitored for weaning from respiratory support in hours after starting respiratory support.

  within 1-2 weeks of respiratory support starting

Secondary Outcomes (4)

• Number of Surfactant Needed

  within first 3 days of assignment

• Respiratory Support Duration

  up to 2 weeks

• Complications related to respiratory support

  Within 1 week after respiratory support discontinuation

• Complication related to prematurity

  Within 1week

Study Arms (2)

Non-invasive High Frequency Oscillatory Ventilation

EXPERIMENTAL

Preterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirefment more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings. Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option.

Device: Non-invasive High Frequency Oscillatory Ventilation

Conventional Invasive Ventilation

ACTIVE COMPARATOR

Preterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirement more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings. Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to invasive ventilation through endotracheal tube, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40.

Device: Conventional Invasive Ventilation

Interventions

Non-invasive High Frequency Oscillatory Ventilation DEVICE

We are planning to use (Medin-CNO) for non-invasive ventilation. This machine has option to deliver NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option.

Also known as: Conventional Invasive Ventilation

Non-invasive High Frequency Oscillatory Ventilation

Conventional Invasive Ventilation DEVICE

Invasive ventilation will be started following endotracheal intubation, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40.

Conventional Invasive Ventilation

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS
• Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation \> 90% on fio2 of 40% in 1st 6 hours of life.
• Capillary PCO2 of \> 70 or arterial PCO2 \> 65 on two repeated sampling within 4 hours
• Neonates whose parents consented to participate.

You may not qualify if:

• All preterm babies who are below \< 26 weeks above the 34 weeks of gestation
• Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support.
• Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis.
• Patient with poor respiratory drive due to any reason neurological or central causes
• Diaphragmatic hernia or any other thoracic anomaly
• Pleural effusion unilateral or bilateral
• Congenital cystic pulmonary malformation.
• Neonates with underlying cyanotic heart disease.
• Neonates with acynotic heart disease causing pulmonary edema
• Neonates with cleft lip and cleft palate or any other surgical condition.

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus Hospital and Health Network

Karachi, Sindh, 75190, Pakistan

Location

Related Publications (10)

• Sankar MJ, Gupta N, Jain K, Agarwal R, Paul VK. Efficacy and safety of surfactant replacement therapy for preterm neonates with respiratory distress syndrome in low- and middle-income countries: a systematic review. J Perinatol. 2016 May;36 Suppl 1(Suppl 1):S36-48. doi: 10.1038/jp.2016.31.

  PMID: 27109091 BACKGROUND

• Wheeler CR, Smallwood CD. 2019 Year in Review: Neonatal Respiratory Support. Respir Care. 2020 May;65(5):693-704. doi: 10.4187/respcare.07720. Epub 2020 Mar 24.

  PMID: 32209710 BACKGROUND

• Boel L, Broad K, Chakraborty M. Non-invasive respiratory support in newborn infants. Paediatrics and Child Health. 2018;28(1):6-12.

  BACKGROUND

• Fischer H. Efficacy and safety of non-invasive respiratory support in neonates. 2018.

  BACKGROUND

• Batey N, Bustani P. Neonatal high-frequency oscillatory ventilation. Paediatrics and Child Health. 2020;30(4):149-53.

  BACKGROUND

• 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 BACKGROUND

• Huang J, Yuan L, Chen C. [Research advances in noninvasive high-frequency oscillatory ventilation in neonates]. Zhongguo Dang Dai Er Ke Za Zhi. 2017 May;19(5):607-611. doi: 10.7499/j.issn.1008-8830.2017.05.025. Chinese.

  PMID: 28506358 BACKGROUND

• Iranpour R, Armanian AM, Abedi AR, Farajzadegan Z. Nasal high-frequency oscillatory ventilation (nHFOV) versus nasal continuous positive airway pressure (NCPAP) as an initial therapy for respiratory distress syndrome (RDS) in preterm and near-term infants. BMJ Paediatr Open. 2019 Jul 14;3(1):e000443. doi: 10.1136/bmjpo-2019-000443. eCollection 2019.

  PMID: 31414062 BACKGROUND

• Shi Y, De Luca D; NASal OscillatioN post-Extubation (NASONE) study group. Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.

  PMID: 31349833 BACKGROUND

• Bottino R, Pontiggia F, Ricci C, Gambacorta A, Paladini A, Chijenas V, Liubsys A, Navikiene J, Pliauckiene A, Mercadante D, Colnaghi M, Tana M, Tirone C, Lio A, Aurilia C, Pastorino R, Purcaro V, Maffei G, Liberatore P, Consigli C, Haass C, Lista G, Agosti M, Mosca F, Vento G. Nasal high-frequency oscillatory ventilation and CO2 removal: A randomized controlled crossover trial. Pediatr Pulmonol. 2018 Sep;53(9):1245-1251. doi: 10.1002/ppul.24120. Epub 2018 Jul 12.

  PMID: 29999596 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Syed RA Rehan Ali, FRCPCH

  The Indus Hospital and Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be done via random allocation software 1.0.0. This software produces as its output a sequence of allocation based on selected type. Considering 2 groups with equal sample size, a simple random allocation list will be generated using block randomization. The list will be used to create Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) to assure allocation concealment. The process of randomization will be conducted by Indus Hospital Research Centre (IHRC) independently.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: June 7, 2021
• Study Start: June 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 12, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)