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CTICU Pacifier Activated Music Player and Mother's Voice

Primary Purpose

Heart Defects, Congenital

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacifier activated music player
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital focused on measuring Congenital heart disease (CCHD), Non-Nutritive Suck

Eligibility Criteria

0 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment prior to surgery

Treatment post surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Oral feeding Efficiency
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

Oral feeding development
Analyzing individual milestones via the American Speech-Language-Hearing Association assessment by speech language pathology, and adverse feeding events.
Neurodevelopment
Evaluating participant's development using Bayley Scales of Infant and Toddler Development (BSID III)

Full Information

First Posted
January 23, 2017
Last Updated
September 19, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT03035552
Brief Title
CTICU Pacifier Activated Music Player and Mother's Voice
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
Congenital heart disease (CCHD), Non-Nutritive Suck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The assessors and the investigator are masked to the group assignment
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment prior to surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment post surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pacifier activated music player
Other Intervention Name(s)
PAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral feeding Efficiency
Description
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.
Time Frame
Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2)
Secondary Outcome Measure Information:
Title
Oral feeding development
Description
Analyzing individual milestones via the American Speech-Language-Hearing Association assessment by speech language pathology, and adverse feeding events.
Time Frame
Thirty days post-operation
Title
Neurodevelopment
Description
Evaluating participant's development using Bayley Scales of Infant and Toddler Development (BSID III)
Time Frame
Twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Maitre, MD. PhD
Organizational Affiliation
Perinatal Research Institute, Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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CTICU Pacifier Activated Music Player and Mother's Voice

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