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

Thrombosis Clinical Trial

Official title:

RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230032
• Other study ID #: IRB16-00862
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cerebral Palsy
• Hemorrhage
• Hydrocephalus
• Infant Development
• Infant,Premature
• Infarction
• Intraventricular Hemorrhage
• Neonatal Encephalopathy
• PVL
• Thrombosis

Intervention

Device:
• pacifier-activated device
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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Cerebral Palsy Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Twelve months
Secondary	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.	3-4 month and 12 month assessments
Secondary	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.	3-4 months and 12 month assessments
Secondary	Oral feeding development questionnaire	Age-calibrated questionnaire (< or > 6 months) in the American Speech-Language-Hearing Association evidence maps for evaluation of feeding problems.	3-4 months and 12 month assessments
Secondary	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.	33-41 weeks PMA and 35-43 weeks PMA