Clinical trial NCT03799861: Newborn Heart Rate as a Catalyst for Improved Survival
Official title: Newborn Heart Rate as a Catalyst for Improved Survival (NeoBeat Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stillbirth
Neonatal Respiratory Depression
Neonatal Bradycardia
Neonatal Resuscitation
Keywords: Neonatal Resuscitation
Stillbirth
Neonatal Respiratory Depression
Neonatal Bradycardia
Lead sponsor: American Academy of Pediatrics
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
name: Laerdal Global Health
name: RTI International
name: Thrasher Research Fund
name: University of North Carolina, Chapel Hill
name: Saving Lives at Birth
First posted: 2019-01-10
Enrollment: 24034
Sex: ALL
Minimum age (years): 28
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns delivered at any of the following 3 maternity units in Kinshasa, DRC over 3 years: Bumbu, Kingasani and Binza-Delvaux. The first 18 months of patients enrolled in the study will be retrospective, while the subsequent 18 months will be prospective. The entire study population will include non-observed and observed deliveries. Observed deliveries will be a convenience sample of non-breathing newborns based on availability of study nurses.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reported Total Stillbirth Rate
timeFrame: At delivery
Secondary outcomes:
measure: Effective, Spontaneous Breathing at 3 Minutes
timeFrame: At 3 minutes of life
Other outcomes:
measure: Fresh Stillbirth Rate
timeFrame: At delivery
measure: Macerated Stillbirth Rate
timeFrame: At delivery
measure: Neonatal Death Prior to Discharge
timeFrame: Up to 28 days of life
measure: Number of Providers Adhering to Resuscitation Algorithm
timeFrame: At delivery
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Binza-Delvaux Maternity Hospital
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Centre Hospital Kingasani
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Mother and Child Hospital Bumbu
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carl Bose, MD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Jackie Patterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Sara Berkelhamer, MD
role: STUDY_CHAIR
affiliation: University of Calgary
name: Nalini Singhal, MD
role: STUDY_CHAIR
References: