Impact of Breast Milk on Cortical Pain Response in Newborns
Condition: Pain Management
Study type: Interventional

Summary: 
      Background:Newborns are exposed to painful procedures for many different reasons in the first
      days of their life. If pain is not relieved effectively in these newborns, neurodevelopmental
      and behavioral problems may occur in the short- and long-term.

      Objective:This study is aimed to investigate the effects of breast milk on cortical pain
      response and behavioral response in newborns during heel-prick procedure.

      Design: A prospective, randomized controlled trial was conducted on newborns born in a
      university hospital. Healthy-term newborns, undergoing heel blood sampling for newborn
      screening, were enrolled in the study. Infants were randomly assigned to study group with
      receive orally 2 ml breast milk (n=45) or a control group with no intervention (n=45) before
      the heel prick. A near-infrared spectroscopy device was used to monitor regional cerebral
      oxygen saturation (rScO2), while neonatal pain expression was assessed by Neonatal Pain,
      Agitation, and Sedation Scale (N-PASS). The rScO2 measure was the primary outcome, while the
      N-PASS score, heart rate, SaO2, and crying time were the secondary outcomes.
    

Detailed description: 
      During the first few days of life, newborns are exposed to painful and stressful
      procedures.1, 2 One of these is the metabolic disease screening test using the heel-prick
      procedures.3, 4 Newborn screening is crucial to detect several congenital genetic and
      metabolic disorders at an early stage for the earliest possible recognition and management of
      affected newborns and to prevent morbidity, mortality, and disabilities associated with
      inherited metabolic disorders5. Pain induced by these procedures is ineffectively prevented
      or inadequately treated1. Consequently, this may have short- and long-term negative effects
      on the pain response and neurodevelopmental outcomes.6, 7, 8 Thus, effectively identifying,
      assessing, and managing neonatal pain are crucial to minimizing its impact on the
      intermediate- and long-term outcomes in newborns.2, 9 Near-infrared spectroscopy (NIRS) is a
      noninvasive technique widely used in neonatal pain research to measure functional activation
      of the cortex.20, 21, 22, 23 NIRS has revealed that blood sampling can activate the neonatal
      somatosensory20, 21, motor24, and prefrontal22 areas starting at the 25th week of
      postmenstrual age. Pain increases oxygen consumption with changes occurring in the primary
      somatosensory cortex on the brain surface.25, 26 Additionally, the relationship between the
      total Premature Infant Pain Profile (PIPP)27 score and hemodynamic response has been
      evaluated.

      Among the analgesics studied for neonatal pain, breast milk is a natural substance beneficial
      and nutritious for infants.32 Whether breast milk administration alters cortical brain
      activation in neonates is presently unclear. Therefore, we conducted a trial to assess
      whether breast milk can relieve cortical pain during a painful metabolic disease screening
      procedure.
    

Intervention name(s): Breastmilk
Intervention type(s): Other
Intervention description(s): Study group with receive orally 2 ml breast milk before the heel prick.
Other intervention name(s): Human milk
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; breastmilk; cortical pain response; heal prick procedure; Near-infrared spectroscopy