Comparison of CPAP Machines With Reusable vs Disposable Circuits

NCT03121612 | Terminated Results DMC

• 1 other identifier: MTTS-01-2017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress syndrome. The assessment will compare a comprehensive list of physiological parameters over the first 72 hours of treatment, and will also monitor rates of side effects and adverse events. The null hypothesis is that infants treated on the two categories of machine (reusable vs disposable) will not differ in relation to key physiological parameters by more than 0.63 standard deviations.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

RDS

Outcome Measures

Primary Outcomes (1)

• FiO2

  Fraction of inspired oxygen (FiO2), measured as a change from baseline as shown on the two machines. Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates; when SpO2 exceeds the target, FiO2 should be reduced. The majority of readings were at SpO2 \> 95%, so FiO2 for these SpO2 readings reflects oxygen provided, not oxygen required to achieve the recommended SpO2 target range (i.e., the FiO2 provided was excessive, by an unknown amount).

  6, 12, 24, 48 and 72 hours after treatment commencement

Secondary Outcomes (18)

• SpO2

  6, 12, 24, 48 and 72 hours after treatment commencement

• Respiratory Rate

  6, 12, 24, 48 and 72 hours after treatment commencement

• Arterial pH

  6, 12, 24, 48 and 72 hours after treatment commencement (where available)

• Partial Pressure of Arterial Oxygen (PaO2)

  6, 12, 24, 48 and 72 hours after treatment commencement (where available)

• Partial Pressure of Arterial Carbon Dioxide (PaCO2)

  6, 12, 24, 48 and 72 hours after treatment commencement (where available)

Study Arms (2)

Dolphin CPAP

EXPERIMENTAL

CPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. \[Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement\]

Device: CPAP

Fisher-Paykel CPAP

ACTIVE COMPARATOR

Fisher-Paykel (F\&P) CPAP machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F\&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask.

Device: CPAP

Interventions

CPAP DEVICE

CPAP therapy

Dolphin CPAP; Fisher-Paykel CPAP

Eligibility Criteria

• Age: 1 Minute - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at Ramaiah Medical College hospital ('inborn infants');
• Infants born elsewhere, and admitted to Ramaiah Medical College hospital under 6 hours of age ("outborn infants");
• Infants with a gestational age at birth (weeks +days) in the range ≥ 28+0 to ≤ 36+6;
• Infants thought to have RDS (clinically diagnosed after onset of respiratory distress \<6 hours of age, sometimes confirmed by X-ray showing homogenous bilateral opacity) who would routinely be provided CPAP therapy; and

You may not qualify if:

• Infants with a 1-minute Apgar score \<3 (as a marker of severe birth asphyxia);
• Infants who received MV prior to randomisation;
• Infants with suspected meconium aspiration syndrome will be excluded to avoid any imbalance in this condition across groups;
• Infants clinically suspected to have another specified serious condition as their main disease process, diagnosed prior to randomisation, specifically: cardiac anomaly, other congenital malformation with respiratory sequelae, septicaemia, pulmonary haemorrhage, pneumothorax, meningitis, poor respiratory effort or recurrent apnoea, or brain haemorrhage (IVH Grades III or IV);
• Infants who have an airway abnormality precluding the use of the standard CPAP interface proposed for this study (e.g., Pierre-Robin sequence, cleft lip or cleft palate) or who have a neuromuscular condition that interferes with respiration;
• Any infant whose treating clinician believes should not be randomised due to some other condition, or for any other reason (reason to be documented).

Sponsors & Collaborators

• Medical Technology Transfer and Services Hong Kong Ltd: lead
• MS Ramaiah Medical College & Hospitals: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

M.S. Ramaiah Medical College

Bangalore, Karnataka, 560054, India

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

1. Sample size achieved (n=51) was fewer than than planned (n=80). 2. Many of the outcomes were affected by a failure to target SpO2 of 90-95% as anticipated in the protocol.

Results Point of Contact

• Title: Dr Gaston Arnolda
• Organization: Arnolda Consulting

gaston.arnolda@gmail.com

+61 2 8068 4963

Study Officials

• G CM Pradeep, MD

  MS Ramaiah Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As the machines are physically distinct, blinding of participants, care providers and investigators is not feasible. The assessment of most outcomes cannot therefore be blinded, with one exception: x-rays for neonates with suspected pneumothorax will be provided to a radiologist for independent verification; the radiologist will not be in the nursery and will therefore be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: April 20, 2017
• Study Start: August 1, 2017
• Primary Completion: August 15, 2018
• Study Completion: October 15, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)