The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
Condition: Hypoxic-Ischemic Encephalopathy; Neonatal Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypothermia
Study type: Interventional

Summary: 
      This research is being done to try to improve the experience of mothers and babies during
      therapeutic hypothermia. Currently, mothers are not able to hold their baby during
      hypothermia treatment. Mothers have reported that not being able to hold their baby during
      this time is stressful. Additionally, it is known that holding has many benefits for mothers'
      and babies' psychological and physical health.

      Therapeutic hypothermia is the standard of care. The experimental interventions of this study
      are to have mothers hold their babies during this treatment, collect saliva samples from
      mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The
      investigators will test saliva of infants and their mothers before and after holding. The
      investigators hope to demonstrate decreased cortisol, a marker for stress, and increased
      oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic
      hypothermia.
    

Detailed description: 
      The inability to hold an infant being treated with therapeutic hypothermia in the neonatal
      intensive care unit has been subjectively reported by ours and other research groups as a
      significant source of stress for parents. The investigators aim to assess the impact of
      holding on endocrinological markers of stress and bonding. Specifically, the investigators
      plan to collect salivary cortisol and oxytocin levels from infants undergoing therapeutic
      hypothermia and their mothers prior to and immediately after a 30-minute holding period.

      The investigators hypothesize that measurable increases in salivary oxytocin levels,
      coinciding with the reported qualitative increased levels of bonding, will be observed after
      the holding period. The investigators anticipate the reported stress reduction after holding
      to be quantified by measurable decreases in salivary cortisol levels. The investigators
      hypothesize these hormone changes will be present in both the mother and the infant when
      compared to samples taken without the holding intervention.
    

Intervention name(s): Holding; Saliva collection; No Holding
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): Mothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin.; Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin; Saliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Infants and mothers will be randomly assigned to the holding condition occurring on the second versus the third day of hypothermia.
On the day of holding, four samples of saliva will be obtained; two from the mother (pre and post holding) and two from the infant (pre and post holding). The first sample will be collected prior to holding, and the second sample immediately at the end of holding before the infant is placed back in the bed.
On the day without holding, four additional samples of saliva will be obtained; two from the mother (pre and post "not holding") and two from the infant (pre and post "not holding").
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Saliva; Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy; Bonding; Oxytocin; Stress; Cortisol