Infant DevelopmentNCT03230032
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
A study testing pacifier-activated device in people with Infant Development and Infant,Premature, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 32 weeks to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Infant,Premature, Hydrocephalus
- What is being tested?
- pacifier-activated device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 weeks to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.
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.
Read the 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.
- Conditions
- Infant Development, Infant,Premature, Hydrocephalus, Neonatal Encephalopathy, Infarction, PVL
- Being tested
- pacifier-activated device
- Medical subject headings
- Premature Birth, Hydrocephalus, Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacifier-activated deviceDevice
Also called PAL
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: pacifier-activated device |
| Control Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve months
Secondary outcomes (4)
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.
Measured: 3-4 month and 12 month assessments
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.
Measured: 3-4 months and 12 month assessments
Oral feeding development questionnaire
Age-calibrated questionnaire (< or > 6 months) in the American Speech-Language-Hearing Association evidence maps for evaluation of feeding problems.
Measured: 3-4 months and 12 month assessments
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.
Measured: 33-41 weeks PMA and 35-43 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start9 Jun 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebral Palsy Alliance
- Responsible party
- Principal investigator, Kristen Benninger, MD, Nationwide Children's Hospital
- Investigators
- Nathalie L Maitre, MD, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230032
- Sponsor's protocol ID
- IRB16-00862
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2017
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kjeldsen CP, Neel ML, Stark AR, He Z, Chorna O, Benninger K, Maitre NL. Contingent mother's voice intervention facilitates attention in hospitalized preterm infants with neural insults. Mind Brain Educ. 2025 Feb;10(1):37-46. doi: 10.1111/mbe.70000. Epub 2025 Feb 22.
PubMed 40486963
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT03230032
- Acronym / sponsor ID
- IRB16-00862
- Conditions
- Infant Development, Infant,Premature, Hydrocephalus, Neonatal Encephalopathy, Infarction, PVL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Cerebral Palsy Alliance
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: pacifier-activated deviceSessions 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. |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 32 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pacifier-activated deviceAlso: PALThe 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 | Device | Intervention Group |
Primary outcome
Oral Feeding Efficiency
Time frame: Twelve months
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.
4 secondary outcomes
HINE
Time frame: 3-4 month and 12 month assessments
Bayley-III
Time frame: 3-4 months and 12 month assessments
Oral feeding development questionnaire
Time frame: 3-4 months and 12 month assessments
NOMAS
Time frame: 33-41 weeks PMA and 35-43 weeks PMA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 40486963Kjeldsen CP, Neel ML, Stark AR, He Z, Chorna O, Benninger K, Maitre NL. Contingent mother's voice intervention facilitates attention in hospitalized preterm infants with neural insults. Mind Brain Educ. 2025 Feb;10(1):37-46. doi: 10.1111/mbe.70000. Epub 2025 Feb 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie L Maitre, MD, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pacifier-activated device in people with Infant Development and Infant,Premature, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Feeding Efficiency (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.