Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03799861
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2018-11-09
Brief Title:
Newborn Heart Rate as a Catalyst for Improved Survival
Sponsor:
American Academy of Pediatrics
Organization:
American Academy of Pediatrics
Study Overview
Official Title:
Newborn Heart Rate as a Catalyst for Improved Survival NeoBeat Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart rate HR is not routinely assessed during newborn resuscitations in low- and lower-middle income countries LMICs Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown
Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions and improvement in outcomes Helping Babies Breathe HBB a resuscitation algorithm developed by the American Academy of Pediatrics AAP is widely accepted as the standard of care for newborn resuscitation in low-resource settings In keeping with the International Liaison Committee on Resuscitation ILCOR recommendations that HR be measured during newborn resuscitation HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement or sooner if there is a helper who can palpateauscultate heart rate However given the frequent reality of a single provider attending deliveries in LMICs as well as the currently available methods for assessing HR ie palpitation or auscultation assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation The effect of low-cost continuous HR monitoring to guide resuscitation in these settings is unknown
NeoBeat is a low-cost battery-operated device designed by Laerdal Global Health for the measurement of newborn HR The device can be placed rapidly on a newborn by a single provider and within 5 seconds displays HR digitally A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67 of newborns classified as stillbirths suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings
This trial will evaluate 1 the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths and 2 the effectiveness of HR-guided HBB on effective breathing at 3 minutes
The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15 compared to standard care The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50 compared to HBB with NeoBeat
Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions and improvement in outcomes Helping Babies Breathe HBB a resuscitation algorithm developed by the American Academy of Pediatrics AAP is widely accepted as the standard of care for newborn resuscitation in low-resource settings In keeping with the International Liaison Committee on Resuscitation ILCOR recommendations that HR be measured during newborn resuscitation HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement or sooner if there is a helper who can palpateauscultate heart rate However given the frequent reality of a single provider attending deliveries in LMICs as well as the currently available methods for assessing HR ie palpitation or auscultation assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation The effect of low-cost continuous HR monitoring to guide resuscitation in these settings is unknown
NeoBeat is a low-cost battery-operated device designed by Laerdal Global Health for the measurement of newborn HR The device can be placed rapidly on a newborn by a single provider and within 5 seconds displays HR digitally A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67 of newborns classified as stillbirths suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings
This trial will evaluate 1 the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths and 2 the effectiveness of HR-guided HBB on effective breathing at 3 minutes
The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15 compared to standard care The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50 compared to HBB with NeoBeat
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None