Newborn Heart Rate as a Catalyst for Improved Survival

NCT03799861 | Completed

• 1 other identifier: 7200AA18FA00010
• Study Type: observational
• Target: 24,034
• Locations: 1 country
• Sites: 3

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

Keywords

Neonatal Resuscitation; Stillbirth; Neonatal Respiratory Depression; Neonatal Bradycardia

Outcome Measures

Primary Outcomes (1)

• Reported Total Stillbirth Rate

  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.

  At delivery

Secondary Outcomes (1)

• Effective, Spontaneous Breathing at 3 Minutes

  At 3 minutes of life

Other Outcomes (4)

• Fresh Stillbirth Rate

  At delivery

• Macerated Stillbirth Rate

  At delivery

• Neonatal Death Prior to Discharge

  Up to 28 days of life

Study Arms (3)

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.

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.

Other: Epoch 3: HR-guided HBB

Interventions

Epoch 2: HBB with NeoBeat 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 2: HBB with NeoBeat

Epoch 3: HR-guided HBB 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).

Epoch 3: HR-guided HBB

Eligibility Criteria

• Age: 28 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Academy of Pediatrics: lead
• Kinshasa School of Public Health: collaborator
• Laerdal Global Health: collaborator
• RTI International: collaborator
• Thrasher Research Fund: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Saving Lives at Birth: collaborator

Study Sites (3)

Binza-Delvaux Maternity Hospital

Kinshasa, Democratic Republic of the Congo

Location

Centre Hospital Kingasani

Kinshasa, Democratic Republic of the Congo

Location

Mother and Child Hospital Bumbu

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Stillbirth

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl Bose, MD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

• Jackie Patterson, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Sara Berkelhamer, MD

  University at Buffalo

  STUDY CHAIR

• Nalini Singhal, MD

  University of Calgary

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 10, 2019
• Study Start: July 5, 2018
• Primary Completion: July 30, 2020
• Study Completion: October 31, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)