Newborn Heart Rate as a Catalyst for Improved Survival

Stillbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799861
• Other study ID #: 7200AA18FA00010
• Status: Completed
• Start date: July 5, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2022
• Source: American Academy of Pediatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24034
• Est. completion date: October 31, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 45 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Depression
• Neonatal Bradycardia
• Neonatal Respiratory Depression
• Neonatal Resuscitation
• Respiratory Insufficiency
• Stillbirth

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.
• 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).

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Binza-Delvaux Maternity Hospital	Kinshasa
Congo, The Democratic Republic of the	Centre Hospital Kingasani	Kinshasa
Congo, The Democratic Republic of the	Mother and Child Hospital Bumbu	Kinshasa

Sponsors (7)

Lead Sponsor	Collaborator
American Academy of Pediatrics	Kinshasa School of Public Health, Laerdal Global Health, RTI International, Saving Lives at Birth, Thrasher Research Fund, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fresh Stillbirth Rate	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.	At delivery
Other	Macerated Stillbirth Rate	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.	At delivery
Other	Neonatal Death Prior to Discharge	Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth.	Up to 28 days of life
Other	Number of Providers Adhering to Resuscitation Algorithm	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.	At delivery
Primary	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	Effective, Spontaneous Breathing at 3 Minutes	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.	At 3 minutes of life