Newborn Heart Rate as a Catalyst for Improved Survival

Completed

• Conditions: Neonatal Bradycardia; Stillbirth; Neonatal Respiratory Depression; Neonatal Resuscitation

• Registration Number: NCT03799861
• Lead Sponsor: American Academy of Pediatrics

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 palpate/auscultate 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 (i.e. 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

Not available

Study Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Primary Completion: 2020-07-30
• Study Completion: 2020-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24034

Inclusion Criteria

all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:

• intrauterine fetal demise
• birth weight
• congenital anomalies
• multiple gestation
• any maternal complication

Exclusion Criteria

• Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
• Miscarriages, or previable newborns, defined as gestational age <28 weeks (or if gestational age is unavailable, birth weight <1,000g) at the time of delivery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reported Total Stillbirth Rate	At delivery	The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant.

Secondary Outcome Measures

Name	Time	Method
Effective, Spontaneous Breathing at 3 Minutes	At 3 minutes of life	Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life.

Trial Locations

Locations (3)

Centre Hospital Kingasani; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

Mother and Child Hospital Bumbu; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

Binza-Delvaux Maternity Hospital; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the