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The NeoBeat Efficacy Study for Newborns

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ClinicalTrials.gov Identifier: NCT03849781
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Sykehuset Østfold
Laerdal Medical
Information provided by (Responsible Party):
Helse Stavanger HF

Study Description
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Brief Summary:
In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.

Condition or disease Intervention/treatment Phase
Newborn Resuscitation Heart Rate Monitoring Device: NeoBeat with a visible display Not Applicable

Detailed Description:

Heart rate assessment immediately after birth in newborn infants is the most important clinical indicator to evaluate the status of a newborn, and critical to the correct guidance of resuscitation efforts.

One of the knowledge gaps identified by the International Liason Committee on Resuscitation (ILCOR) is how best to assess ventilation during newborn resuscitation, and improved technology for rapid application of ECG.

Laerdal Medical has developed a novel heart rate meter, NeoBeat, implementing ECG dry-electrodes in a snug-fit abdomen-shaped buckle for for rapid application on the newborn.

In a multicenter randomized controlled trial the investigators will study the efficacy of NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous respiration after birth.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention
NeoBeat will be placed on all newborns immediately after birth to assess the heartrate for at least 5 minutes, or longer if the newborn needs resuscitation. Intervention subjects will have a visible display of the heart rate on the NeoBeat, to guide healthcare providers in further management of the newborn.
 Device: NeoBeat with a visible display
NeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation.
No Intervention: Standard Care
NeoBeat will be placed on the newborn to collect information on heart rate, but heart rate is not displayed to the healthcare providers. If the newborn is in need of resuscitation to initiate spontaneous respiration, the baby will be transferred to the resuscitation bay. According to recommendations the heart rate should be assessed and positive pressure ventilation initiated within one minute of life. Standard care is to assess heart rate by conventional ECG and/or pulse oximetry, alternatively auscultation of the heart.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns [ Time Frame: First minute after birth ]
    Defined as initiation of PPV within on minute


Secondary Outcome Measures :
  1. Change in time from birth to initiation of PPV [ Time Frame: first 15 minutes of life ]
    defined as seconds between birth and initiation of PPV

  2. Change in total duration of PPV [ Time Frame: first hour of life ]
    defined as seconds of PPV in total

  3. Change in time from birth to a stable HR ≥100 and 120 bpm [ Time Frame: first hour of life ]
    defined as HR ≥100 and 120 bpm for ≥ 60 seconds after discontinuing PPV

  4. Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation [ Time Frame: first hour of life ]
    defined as seconds between birth to reach saturation values ≥ 95% without oxygen supplementation

  5. Adequate Vt delivered during PPV [ Time Frame: first hour of life ]
    defined as proportion of time of PPV with Vt ≥ 6 ml/kg

  6. Change in ventilation fraction [ Time Frame: first hour of life ]
    defined as cumulative number of seconds with PPV efforts excluding pauses

  7. Change in number of infants with Apgar score <7 at 5 and 10 minutes [ Time Frame: first 10 minutes of life ]
    Apgar score at 5 and 10 minutes

  8. Change in NICU admission rate after resuscitation [ Time Frame: first hour of life ]
    defined as percentage of newborns needing admission to the NICU after resuscitation


Eligibility Criteria
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Ages Eligible for Study:   up to 60 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment

Exclusion Criteria:

Congenital malformations that interfere with the intervention, Non-consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849781


Contacts
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Contact: Siren I Rettedal, PhD +47 45235742 siren.irene.rettedal@sus.no
Contact: Hege Ersdal, PhD 05151 hege.ersdal@safer.net

Locations
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Norway
Stavanger University Hospital Recruiting
Stavanger, Rogaland, Norway, 4068
Contact: Siren I Rettedal, PhD    +47 45235742    siren.irene.rettedal@sus.no   
Contact: Hege L Ersdal, Associate Professor    +47 99647822    hege.ersdal@safer.net   
Sponsors and Collaborators
Helse Stavanger HF
Sykehuset Østfold
Laerdal Medical
Investigators
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Study Director: Svein Skeie, MD PhD Stavanger University Hosptial
More Information
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03849781    
Other Study ID Numbers: SUS2019SIR
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No