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CTICU Pacifier Activated Music Player and Mother's Voice

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ClinicalTrials.gov Identifier: NCT03035552
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2017
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Nathalie Maitre, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Behavioral: Pacifier activated music player Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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)
Masking Description: The assessors and the investigator are masked to the group assignment
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Improve Oral Feeding Outcomes in Infants With Complex Congenital Heart Disease Using Pacifier Activated Device-Training With Mother's Voice
Actual Study Start Date : September 15, 2016
Estimated Primary Completion Date : February 8, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment prior to surgery
Infants randomized to receive the pacifier activated music player and mother's voice treatment prior to surgery for 5 sessions, and mother's voice playing freely post surgery.
Behavioral: Pacifier activated music player
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 Name: PAM

Experimental: Treatment post surgery
Infants randomized to receive the mother's voice playing freely prior to surgery,and pacifier activated music player and mother's voice treatment post surgery for 5 sessions.
Behavioral: Pacifier activated music player
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 Name: PAM




Primary Outcome Measures :
  1. Oral feeding Efficiency [ Time Frame: Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2) ]
    Continuous measure of suck strength and suck rate during oral feeding via PAM sensor, as well as suck burst pattern and average oral feeding volumes.


Secondary Outcome Measures :
  1. Oral feeding development [ Time Frame: Thirty days post-operation ]
    Analyzing individual milestones via the American Speech-Language-Hearing Association assessment by speech language pathology, and adverse feeding events.

  2. Neurodevelopment [ Time Frame: Twelve months ]
    Evaluating participant's development using Bayley Scales of Infant and Toddler Development (BSID III)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 malformation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035552


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
American Heart Association
Investigators
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Principal Investigator: Nathalie Maitre, MD. PhD Perinatal Research Institute, Nationwide Children's Hospital

Publications:

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Responsible Party: Nathalie Maitre, MD, PhD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03035552     History of Changes
Other Study ID Numbers: IRB16-00493
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nathalie Maitre, Nationwide Children's Hospital:
Congenital heart disease (CCHD)
Non-Nutritive Suck

Additional relevant MeSH terms:
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Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases