Newborn Heart Rate as a Catalyst for Improved Survival
Condition: Stillbirth; Neonatal Respiratory Depression; Neonatal Bradycardia; Neonatal Resuscitation
MeSH terms: Respiratory Insufficiency; Stillbirth; Bradycardia; Depression
Study type: Observational

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.
    


Intervention name(s): Epoch 2: HBB with NeoBeat; Epoch 3: HR-guided HBB
Intervention type(s): Other; Other
Intervention description(s): 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.; 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).
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Neonatal Resuscitation; Stillbirth; Neonatal Respiratory Depression; Neonatal Bradycardia