Newborn Heart Rate as a Catalyst for Improved Survival

NCT ID: NCT03799861

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24034 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2020-10-31

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.

Conditions

Stillbirth; Neonatal Respiratory Depression; Neonatal Bradycardia; Neonatal Resuscitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Epoch 2: HBB with NeoBeat

Intervention Type: OTHER

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.

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.

Epoch 3: HR-guided HBB

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 45 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kinshasa School of Public Health

OTHER

Sponsor Role: collaborator

Laerdal Global Health

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Saving Lives at Birth

UNKNOWN

Sponsor Role: collaborator

American Academy of Pediatrics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Bose, MD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Jackie Patterson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Sara Berkelhamer, MD

Role: STUDY_CHAIR

University at Buffalo

Nalini Singhal, MD

Role: STUDY_CHAIR

University of Calgary

Locations

Binza-Delvaux Maternity Hospital

Kinshasa, , Democratic Republic of the Congo

Centre Hospital Kingasani

Kinshasa, , Democratic Republic of the Congo

Mother and Child Hospital Bumbu

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

7200AA18FA00010

Identifier Type: -

Identifier Source: org_study_id