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Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

Primary Purpose

Infant Development, Infant,Premature, Hydrocephalus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pacifier-activated device
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Development

Eligibility Criteria

32 Weeks - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PMA at enrollment >32 6/7 and <42 AND
  • Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR
  • Abnormal GMA by certified study staff and masked gold-standard reading

Exclusion Criteria: Infants cannot be

  • on assisted ventilation
  • receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start
  • receiving less than 50% of their feeds enterally
  • receiving enteral feed for greater than 60 min.
  • considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Sessions will use a pacifier-activated device (PAL) system. The device sensor attaches to a routinely-used pacifier and measures timing and pressure of the sucks. If the infant reaches the preset suck pressure, he receives 10 seconds of mother's voice. The receiver/speaker box controls the volume to < 65dB on scale C. PAM will be set to the lowest settings for the first session. Using sensor measurements, the therapist will increase the threshold for number of sucks and strength once the infant produces three consecutive sucks above current level and continue per protocol.

Infants will receive 2 daily 15-min listening sessions of mother's voice recording, contiguous but not simultaneous with PAM NNS sessions without suck-contingent reinforcement (no voice).

Outcomes

Primary Outcome Measures

Oral Feeding Efficiency
Continuous measure of suck strength and suck rate during non-nutritive suck via PAM sensor, as well as suck burst pattern and average oral feeding volumes.

Secondary Outcome Measures

HINE
Hammersmith Infant Neurologic Exam (HINE): standardized and scored neurological examination for infants 2-24 months; sequential use allows identification of early signs of CP and other neuromotor disorders. It includes 26 items assessing cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Each item is scored individually (0, 1, 2 or 3), with a sum score of all individual items (range: 0-78). The maximum score for any one item is a score of 3 and the minimum is a score of 0.
Bayley-III
Bayley Scales of Infant and Toddler Development (Bailey-III): Standardized comprehensive assessment tool for assessing child development in children one month to 42 months old. Subtests assess adaptive behavior, cognitive, language, motor, and social-emotional domains. The highest possible scaled score on each subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average. Composite scores are derived for each domain from sums of subtest scaled scores. Composite scores range from 40-160.
Oral feeding development questionnaire
Age-calibrated questionnaire (< or > 6 months) in the American Speech-Language-Hearing Association evidence maps for evaluation of feeding problems.
NOMAS
Neonatal Oral-Motor Assessment Scale (NOMAS): A tool for the evaluation of neonatal nutritive sucking patterns in pre-term and term infants. Sub-scores are made up of dichotomous assessments of jaw and tongue movements during a feed. An overall sucking pattern of "normal," "disorganized," or "dysfunctional" is determined based on the items checked in each category.

Full Information

First Posted
June 22, 2017
Last Updated
September 11, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Cerebral Palsy Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT03230032
Brief Title
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
Official Title
RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Cerebral Palsy Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.
Detailed Description
Poor neuromotor and sensory function of the aerodigestive system in children with CP often originates in the neonatal period, when they are still classified as "high-risk for CP". Characteristic neuroimaging abnormalities including severe intraventricular (IVH) hydrocephalus and periventricular leukomalacia (PVL), stroke or ischemia with lesions affect the posterior limb of the internal capsule are strong Indicators of high-risk for CP, especially when combined with abnormal General Movements Assessment (Guidelines for Early Detection of CP; Stockholm, 2016). Early intervention, when plasticity is greatest has the largest impact on functional recovery in CP. While intervening in infancy involves treating some infants who will not develop CP, the goal is to establish new neuronal connections and functional patterns before less efficient adaptations can occur. However, no current interventions target the oral-motor dysfunction of infants at high-risk for CP, before their discharge from the NICU. Evidence for behavioral interventions in feeding disorders for children with CP ranges from insufficient to moderate, with a clear need for rigorous studies. In healthy preterm and late-preterm infants, oromotor practice opportunities such as non-nutritive suck (NNS) are safe and promote effective suck-swallow-breathe patterns, with decreased time to achieving oral feeds. While NNS opportunities are frequent in most NICUs, they must be adapted for effectiveness in infants at high-risk for CP. Motor learning in these infants must incorporate repetitive, self-initiated and task-directed activities. Learning is optimized when contingent on feedback, such as positive reinforcement. NNS training (rather than simple exposure) has been implemented successfully using rhythmic sound of mother's voice singing contingent upon suck strength and pattern, as detected by a pacifier-sensor device (Pacifier-activated music; PAM) in an cohort of predominantly healthy preterm infants. An RCT demonstrated that NNS-trained infants had feeding tubes removed one week earlier than controls, with fewer aspiration events and feeding difficulties in infancy. The intervention was promising in the dozen infants with significant neural injury. Following this preliminary data, this study seeks to further determining the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development, Infant,Premature, Hydrocephalus, Neonatal Encephalopathy, Infarction, PVL, Thrombosis, Intraventricular Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There participants will be randomized to two groups: PAL (pacifier and mother's voice provided contingently on sucking behavior) or Sounds of Love (listening to mother's voice not contingent upon sucking behavior on the pacifier, but pacifier available, per standard of care). To allow for high repetitiveness of the treatment, participants in both groups will receive 2 daily 15-min sessions of the intervention or control treatments for a total of 20 sessions. Sessions occur 15-30 min prior to feeding.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Sessions will use a pacifier-activated device (PAL) system. The device sensor attaches to a routinely-used pacifier and measures timing and pressure of the sucks. If the infant reaches the preset suck pressure, he receives 10 seconds of mother's voice. The receiver/speaker box controls the volume to < 65dB on scale C. PAM will be set to the lowest settings for the first session. Using sensor measurements, the therapist will increase the threshold for number of sucks and strength once the infant produces three consecutive sucks above current level and continue per protocol.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Infants will receive 2 daily 15-min listening sessions of mother's voice recording, contiguous but not simultaneous with PAM NNS sessions without suck-contingent reinforcement (no voice).
Intervention Type
Device
Intervention Name(s)
pacifier-activated device
Other Intervention Name(s)
PAL
Intervention Description
The utilization of the pacifier-activated-music player combines the sound of the mother's voice with a pacifier routinely used with each patient during their inpatient NICU stay
Primary Outcome Measure Information:
Title
Oral Feeding Efficiency
Description
Continuous measure of suck strength and suck rate during non-nutritive suck via PAM sensor, as well as suck burst pattern and average oral feeding volumes.
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
HINE
Description
Hammersmith Infant Neurologic Exam (HINE): standardized and scored neurological examination for infants 2-24 months; sequential use allows identification of early signs of CP and other neuromotor disorders. It includes 26 items assessing cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Each item is scored individually (0, 1, 2 or 3), with a sum score of all individual items (range: 0-78). The maximum score for any one item is a score of 3 and the minimum is a score of 0.
Time Frame
3-4 month and 12 month assessments
Title
Bayley-III
Description
Bayley Scales of Infant and Toddler Development (Bailey-III): Standardized comprehensive assessment tool for assessing child development in children one month to 42 months old. Subtests assess adaptive behavior, cognitive, language, motor, and social-emotional domains. The highest possible scaled score on each subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average. Composite scores are derived for each domain from sums of subtest scaled scores. Composite scores range from 40-160.
Time Frame
3-4 months and 12 month assessments
Title
Oral feeding development questionnaire
Description
Age-calibrated questionnaire (< or > 6 months) in the American Speech-Language-Hearing Association evidence maps for evaluation of feeding problems.
Time Frame
3-4 months and 12 month assessments
Title
NOMAS
Description
Neonatal Oral-Motor Assessment Scale (NOMAS): A tool for the evaluation of neonatal nutritive sucking patterns in pre-term and term infants. Sub-scores are made up of dichotomous assessments of jaw and tongue movements during a feed. An overall sucking pattern of "normal," "disorganized," or "dysfunctional" is determined based on the items checked in each category.
Time Frame
33-41 weeks PMA and 35-43 weeks PMA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PMA at enrollment >32 6/7 and <42 AND Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR Abnormal GMA by certified study staff and masked gold-standard reading Exclusion Criteria: Infants cannot be on assisted ventilation receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start receiving less than 50% of their feeds enterally receiving enteral feed for greater than 60 min. considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie L Maitre, MD, PhD
Organizational Affiliation
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
Undecided

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Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

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