CTICU Pacifier Activated Music Player and Mother's Voice
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)
      using contingent positive reinforcement with mother's voice can improve the feeding outcomes
      of infants with congenital heart defect (CHD) at high risk for oral motor problems.
    

Detailed description: 
      Randomized controlled trial to Improve Oral Feeding Outcomes in Infants with Complex
      Congenital heart disease using Pacifier Activated Device-Training with Mother's Voice
      Specific Aims Infants with complex congenital heart disease (CCHD) have high rates of delayed
      or impaired oral feeding skills, associated with other neurodevelopmental problems such as
      worse motor and language outcomes in early childhood. The acquisition of efficient suck
      strength and patterns is essential to promote later optimal oral feeding. Therefore,
      ineffective non-nutritive suck (NNS), one of the earliest feeding milestones, can result in
      later maladaptive oral motor skills or even oro-sensory aversions. Evidence-based
      interventions are lacking for CCHD infants hospitalized in the Cardiothoracic Intensive Care
      Unit (CTICU) to improve early oral feeding patterns and promote acquisition of later
      developmental milestones. NNS training (as opposed to simply offering a pacifier) safely
      improves oral feeding strength and rate in other high-risk populations, such as preterm
      infants, even when they have suffered severe neural insults. This type of training uses
      operant conditioning with positive stimuli to reinforce learning and establishment of
      functional pathways between lower and higher order neural networks. Furthermore, NNS training
      is associated with acquisition of essential developmental milestones in the first year. The
      investigators propose the following hypothesis: Intensive NNS-contingent training using
      reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD.
      They further hypothesize that establishment of optimal NNS in the first 6 months can improve
      feeding and developmental outcomes by one year of age.

      To test this hypothesis, the investigators propose a randomized controlled trial (RCT) in
      CCHD infants hospitalized for surgical repair. Because the proposed intervention has been
      demonstrated to only have positive effects in other high-risk infants, the study will use a
      wait-list design: CCHD infants who do not receive their intervention before surgery will
      receive it after, so that the entire cohort will eventually benefit from the intervention.
      The intervention will utilize a Pacifier Activated Music Player (PAM) with a sensor detecting
      changes in suck pressures and patterns, and a speaker contingently delivering mother's voice,
      in infants 0-6 months in the CTICU. Quantitative oral feeding metrics before and after the
      intervention, as well as, immediately after discharge will be used to measure efficacy.
      Secondly, to assess the impact of NNS training on developmental milestone acquisition, a
      standardized feeding and neurodevelopmental assessments of all trial infants at 12 months of
      age in the Follow-Up clinic will also be conducted. Randomization will account for
      differences in CCHD diagnoses known to impact outcomes. The study design will control for the
      type of surgical procedure as a proxy for severity of illness and exposure to anesthesia and
      for variables associated with neurodevelopment such as maternal education and prematurity.

      Aim 1 A: Compare oral feeding skills as measured by suck strength, rate and burst patterns in
      CCHD infants with vs. without NNS training using PAM/mother's voice prior to surgery, in an
      RCT design. Aim 1 B: Correlate improvements in oral feeding skills after NNS training with
      PAM/mother's voice in the entire study cohort with higher scores on standardized feeding
      questionnaires at 1 month after discharge. Aim 2: Demonstrate that improvements in oral
      feeding skills in the CTICU will correlate with better neurodevelopmental outcomes as
      measured by standardized scores on the Bayley Scales of Infant and Toddler Development (BSID
      III) at 12 months. This study holds significant public health relevance as it validates an
      inexpensive, parent-centered rehabilitative strategy for infants at high-risk for impaired
      oral feeding skills, with a device and approach easily adapted to many levels of CCHD care
      and with the potential to improve longer-term neurodevelopment.
    

Intervention name(s): Pacifier activated music player
Intervention type(s): Behavioral
Intervention description(s): Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.
Other intervention name(s): PAM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized to Pacifier Activated Lullaby (mother's voice contingent on suck, 15 minutes, 5 sessions) before surgery or and Sounds of Love (mother's voice playing freely, 15 minutes, 5 sessions). Arm 2: Sounds of love before surgery, Pacifier activated lullaby after the surgery.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Congenital heart disease (CCHD); Non-Nutritive Suck