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Newborn Heart Rate as a Catalyst for Improved Survival

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ClinicalTrials.gov Identifier: NCT03799861
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Kinshasa School of Public Health
Laerdal Global Health
RTI International
Thrasher Research Fund
University of North Carolina, Chapel Hill
Saving Lives at Birth
Information provided by (Responsible Party):
American Academy of Pediatrics

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.


Condition or disease Intervention/treatment
Stillbirth Neonatal Respiratory Depression Neonatal Bradycardia Neonatal Resuscitation Other: Epoch 2: HBB with NeoBeat Other: Epoch 3: HR-guided HBB

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Study Type : Observational
Estimated Enrollment : 29034 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Newborn Heart Rate as a Catalyst for Improved Survival (NeoBeat Study)
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Group/Cohort Intervention/treatment
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
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.
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   28 Weeks to 45 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799861


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

Locations
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Congo, The Democratic Republic of the
Binza-Delvaux Maternity Hospital Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Adrien Lokangaka, MD, MPH    +243 854426233    adrinloks@yahoo.fr   
Centre Hospital Kingasani Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Adrien Lokangaka, MD, MPH    +243 854426233    adrinloks@yahoo.fr   
Mother and Child Hospital Bumbu Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Adrien Lokangaka, MD, MPH    +243 854426233    adrinloks@yahoo.fr   
Sponsors and Collaborators
American Academy of Pediatrics
Kinshasa School of Public Health
Laerdal Global Health
RTI International
Thrasher Research Fund
University of North Carolina, Chapel Hill
Saving Lives at Birth
Investigators
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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
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Responsible Party: American Academy of Pediatrics
ClinicalTrials.gov Identifier: NCT03799861    
Other Study ID Numbers: 7200AA18FA00010
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Academy of Pediatrics:
Neonatal Resuscitation
Stillbirth
Neonatal Respiratory Depression
Neonatal Bradycardia
Additional relevant MeSH terms:
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Respiratory Insufficiency
Stillbirth
Bradycardia
Depression
Behavioral Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Fetal Death
Pregnancy Complications
Death
Respiration Disorders
Respiratory Tract Diseases