Tracking Information

First Submitted Date

November 9, 2018

First Posted Date

January 10, 2019

Last Update Posted Date

May 7, 2020

Actual Study Start Date

July 5, 2018

Estimated Primary Completion Date

May 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Reported Total Stillbirth Rate [ Time Frame: 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.

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Effective, Spontaneous Breathing at 3 Minutes [ Time Frame: 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.

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Fresh Stillbirth Rate [ Time Frame: At delivery ]
Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births.
Macerated Stillbirth Rate [ Time Frame: At delivery ]
Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births.
Neonatal Death Prior to Discharge [ Time Frame: Up to 28 days of life ]
Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth.
Number of Providers Adhering to Resuscitation Algorithm [ Time Frame: At delivery ]
any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm.

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title

Newborn Heart Rate as a Catalyst for Improved Survival

Official Title

Newborn Heart Rate as a Catalyst for Improved Survival (NeoBeat Study)

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 Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Stillbirth
Neonatal Respiratory Depression
Neonatal Bradycardia
Neonatal Resuscitation

Intervention

Other: Epoch 2: HBB with NeoBeat
At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs.
Other: Epoch 3: HR-guided HBB
At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs).

Study Groups/Cohorts

Epoch 1: Care prior to HBB training
A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training.
Epoch 2: HBB with NeoBeat
Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period.

Intervention: Other: Epoch 2: HBB with NeoBeat
Epoch 3: HR-guided HBB
Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period.

Intervention: Other: Epoch 3: HR-guided HBB

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

29034

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

May 15, 2020

Estimated Primary Completion Date

May 15, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

28 Weeks to 45 Weeks (Child)

Accepts Healthy Volunteers

Yes

Contacts

Contact: Adrien Lokangaka, MD, MPH	+243 854426233	adrinloks@yahoo.fr
Contact: Daniel Ishoso, MD	+243 821605955	dishosok@gmail.com

Listed Location Countries

Congo, The Democratic Republic of the

Removed Location Countries

Administrative Information

NCT Number

NCT03799861

Other Study ID Numbers

7200AA18FA00010

Has Data Monitoring Committee

No

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

American Academy of Pediatrics

Study Sponsor

American Academy of Pediatrics

Collaborators

Kinshasa School of Public Health
Laerdal Global Health
RTI International
Thrasher Research Fund
University of North Carolina, Chapel Hill
Saving Lives at Birth

Investigators

Study Director:	Carl Bose, MD	University of North Carolina, Chapel Hill
Principal Investigator:	Jackie Patterson, MD, MPH	University of North Carolina, Chapel Hill
Study Chair:	Sara Berkelhamer, MD	University at Buffalo
Study Chair:	Nalini Singhal, MD	University of Calgary

PRS Account

American Academy of Pediatrics

Verification Date

May 2020

免费获得国外治疗治疗心动过缓相关药品，最快 1 个工作日回馈药物信息

Newborn Heart Rate as a Catalyst for Improved Survival

study details

table view