Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures
Condition: Preterm Infants; Stress
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of
      supportive interventions on preterm infants' stress (salivary cortisol and
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,
      and physical activity in the NICU, and (2) to explore the relationships among preterm
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,
      and physical activity. This randomized controlled trial will adopt a longitudinal
      repeated-measures design to examine the effects of bundled supportive interventions on
      preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and
      physiological signals of infant distress [using bedside electrocardiographic monitors]),
      sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.
      Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two
      conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine
      kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive
      interventions (usual NICU care +positioning + gentle touch + modulating infant states +
      facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome
      variables will include infants' biological responses to stress (salivary cortisol, salivary
      DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
    

Detailed description: 
      Background and purpose: Preterm infants need to receive intensive care in a neonatal
      intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a
      stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change
      their physiological indicators, and affect their developing brain and organs, possibly
      resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians
      caring for these vulnerable infants have two important goals: to provide early interventions
      to minimize preterm infants' stress/pain and to improve their sleep and physical activity.
      The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of
      supportive interventions on preterm infants' stress (salivary cortisol and
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,
      and physical activity in the NICU, and (2) to explore the relationships among preterm
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,
      and physical activity.

      Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design
      to examine the effects of bundled supportive interventions on preterm infants' stress
      (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant
      distress [using bedside electrocardiographic monitors]), sleep and physical activity (using
      ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the
      study criteria will be randomly assigned to one of two conditions: (1) control condition:
      usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20
      minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care
      +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive
      sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants'
      biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals
      of infant distress), sleep patterns, and physical activity.

      Expected outcomes: The study will fill a gap in knowledge about the effects of bundled
      supportive interventions on preterm infants' stress reactivity, sleep, and physical activity
      during hospitalization. This unique combination of physiological measurements of preterm
      infants' stress parameters and longitudinal design will provide results for establishing
      evidence-based clinical guidelines to provide atraumatic care to this population during
      intrusive procedures. Investigators also expect that bundling supportive interventions will
      minimize preterm infants' pain/stress as well as improve their sleep and physical activity.
      In the long term, the study results may help reduce the morbidity and complications due to
      preterm birth, save medical costs in neonatal care, and promote these infants' health and
      future developmental outcomes.
    

Intervention name(s): The bundle of supportive interventions; Usual NICU care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes; usual NICU care + positioning + gentle touch +routine KMC < 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Preterm infant; Stress; Salivary DHEA; Salivary cortisol; Actigraphy