NCT03849781

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

January 30, 2019

Last Update Submit

May 13, 2019

Conditions

Newborn ResuscitationHeart Rate Monitoring

Outcome Measures

Primary Outcomes (1)

  • Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns

    Defined as initiation of PPV within on minute

    First minute after birth

Secondary Outcomes (8)

  • Change in time from birth to initiation of PPV

    first 15 minutes of life

  • Change in total duration of PPV

    first hour of life

  • Change in time from birth to a stable HR ≥100 and 120 bpm

    first hour of life

  • Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation

    first hour of life

  • Adequate Vt delivered during PPV

    first hour of life

  • +3 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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.

Interventions

NeoBeat with a visible displayDEVICE

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.

Intervention

Eligibility Criteria

AgeUp to 60 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Congenital malformations that interfere with the intervention, Non-consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

RECRUITING

Related Publications (2)

  • Rettedal S, Kibsgaard A, Kvaloy JT, Eilevstjonn J, Ersdal HL. Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):371-377. doi: 10.1136/archdischild-2023-325878.

    PMID: 37940377DERIVED

  • Rettedal S, Kibsgaard A, Eilevstjonn J, Kvaloy JT, Bjorland PA, Markhus Pike H, Haynes J, Tysland TB, Stordal K, Holte K, Davis PG, Ersdal HL. Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 7;12(9):e061839. doi: 10.1136/bmjopen-2022-061839.

    PMID: 36691167DERIVED

Study Officials

  • Svein Skeie, MD PhD

    Stavanger University Hosptial

    STUDY DIRECTOR

Central Study Contacts

Siren I Rettedal, PhD

CONTACT

+47 45235742siren.irene.rettedal@sus.no

Hege Ersdal, PhD

CONTACT

05151hege.ersdal@safer.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 21, 2019

Study Start

March 8, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)