CTICU Pacifier Activated Music Player and Mother's Voice

Status:Enrolling by invitation
Conditions:Cardiology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Age Range:Any
Start Date:September 15, 2016
End Date:December 31, 2019

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Randomized Controlled Trial to Improve Oral Feeding Outcomes in Infants With Complex Congenital Heart Disease Using Pacifier Activated Device-Training With Mother's Voice

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.

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.

Inclusion Criteria:

- Infants that have a diagnosis of a complex congenital heart defect and scheduled for a
surgical intervention; meet CTICU feeding guidelines criteria. Infants with acquired
brain injury will be included, as well as those whose mothers speak languages other
than English.

Exclusion Criteria:

- Infants that are on assisted ventilation, continuous positive airway pressure, general
anesthesia within 24 hours; lethal congenital abnormalities or congenital brain
We found this trial at
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Columbus, OH
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